{"id":1092,"date":"2017-02-07T11:28:23","date_gmt":"2017-02-07T11:28:23","guid":{"rendered":"http:\/\/wwwro.anm.ro\/?page_id=1092"},"modified":"2017-04-19T10:14:09","modified_gmt":"2017-04-19T10:14:09","slug":"anunturi-importante-dispozitive-medicale","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/anunturi-importante-dispozitive-medicale\/","title":{"rendered":"Important notifications \u2013 Medical Devices"},"content":{"rendered":"<div class=\"anunturi\"><ul class=\"display-posts-listing\"><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-23-02-2026\/\">Important notification<\/a><div class=\"content\"><p><strong>23.02.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices of Romania (NAMMDR) has been informed about the marketing within the European Union of counterfeit units of \u201cCOVID-19 and Influenza A+B Antigen Combo Rapid Test For Self-testing\u201d, with reference FCO-6032 and batch number FCO24090516, manufactured by Safecare Biotech (Hangzhou) Co., Ltd., China.<br \/>\nAccording to the information held by the NAMMDR, counterfeit products can be identified by the following elements:<br \/>\nA label containing modified information regarding the batch number, manufacturing date and expiry date has been applied to the packaging, as follows:<br \/>\n\u2013 Batch number: FCO24090516<br \/>\n\u2013 Manufacturing date: 09\/2024<br \/>\n\u2013 Expiry date: 09\/2026<br \/>\n\u2013 The batch number and expiry date have been removed from the test cassette included in the kit, so only the following symbols appear:<br \/>\n\u2013 The expiry date has been removed from the tube containing the extraction solution (buffer).<br \/>\n\u2013 The swab included in the kit is not the same as the one used by the original manufacturer of the product. The original manufacturer of the swabs is Dalian Rongbang Medical Healthy Devices Co. Ltd., with their authorised representative -Lotus NL, BV (Netherlands).<br \/>\nIn addition, another counterfeit batch with number FCO2023020312 was identified in the European Union, while the original batch number is FCO20230203.<br \/>\n<strong>If you have come into possession of such medical devices or are aware of distributors who sell such medical devices on Romanian territory, do not use them and notify the National Agency for Medicines and Medical Devices of Romania using the contact details posted on the NAMMDR website.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-28-01-2026\/\">Important notification<\/a><div class=\"content\"><p><strong>28.01.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all interested parties<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices of Romania has been informed about the presence on the EU and non-EU market of a software developed by manufacturer Therapeak B.V., the Netherlands, which offers patients treatment plans, following registration on the website, completion of a questionnaire and participation in 30-minute sessions with a therapist generated by artificial intelligence, depending on the declared health condition.<br \/>\nSince this software has a medical purpose, for diagnosis and\/or treatment of a disease, but does not meet the regulatory requirements applicable to medical devices in Regulation (EU) 2017\/745 on medical devices (lack of a EU certificate of conformity issued by a Notified Body), the Competent Authority for medical devices in the Netherlands has requested the manufacturer to withdraw this non-compliant software from the EU market.<br \/>\n<strong>Under these conditions, the National Agency for Medicines and Medical Devices of Romania warns all interested parties to show increased attention, not to access websites that refer to this non-compliant software or, if they have already accessed it, not to consider the treatment plans generated through artificial intelligence by this software, but instead to follow the treatment plans established by medical professionals in Romania who have them on record for the respective health conditions.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-26-01-2026\/\">Important notification<\/a><div class=\"content\"><p><strong>26.01.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of users and economic operators carrying out activities with medical devices<\/strong><\/span><br \/>\nPlease be informed that starting with January 2026, the tariffs for the activities carried out by the National Agency for Medicines and Medical Devices of Romania in the field of medical devices have been indexed with the average inflation rate of 2025 and can be found in Annex 1, hereby attached.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/Anexa 1 Cuantum tarife indexate 2026.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-28-11-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>28.11.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all interested parties<\/strong><\/span><br \/>\nThe European Commission published in the Official Journal of the European Union Commission Decision (EU) 2025\/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices (EUDAMED):<br \/>\n<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/RO\/TXT\/PDF\/?uri=OJ:L_202502371\" target=\"_blank\">https:\/\/eur-lex.europa.eu\/legal-content\/RO\/TXT\/PDF\/?uri=OJ:L_202502371<\/a><br \/>\nThis confirms that the following electronic systems included in the EUDAMED are functional and meet the functional specifications mentioned in Article 34(2) of Regulation (EU) 2017\/745:<br \/>\n\u2022 the electronic system for the registration of economic operators (<strong>Actor registration<\/strong>) \u2013 referred to in Article 30 of Regulation (EU) 2017\/745(MDR) and in Article 27 of Regulation (EU) 2017\/746(IVDR);<br \/>\n\u2022 the UDI database and the electronic system for device registration (<strong>UDI\/Device registration<\/strong>) \u2013 referred to in Articles 28 and 29 of Regulation (EU) 2017\/745(MDR) and in Articles 25 and 26 of Regulation (EU) 2017\/746(IVDR);<br \/>\n\u2022 the electronic system for notified bodies and certificates (<strong>Notified Bodies and Certificates module<\/strong>) \u2013 referred to in Article 57 of Regulation (EU) 2017\/745(MDR) and in Article 52 of Regulation (EU) 2017\/746(IVDR);<br \/>\n\u2022 the electronic market surveillance system (<strong>Market Surveillance<\/strong>) \u2013 referred to in Article 100 of Regulation (EU) 2017\/745(MDR) and in Article 95 of Regulation (EU) 2017\/746(IVDR).<br \/>\nThe obligations and requirements related to the Eudamed apply from the date corresponding to a 6-month period from the date of the aforementioned publication (according to Article 123 of the MDR, Article 113 of the IVDR), namely from <strong>28 May 2026<\/strong>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-07-10-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>07.10.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all interested parties<\/strong><\/span><br \/>\nWhere distributors or importers carry out any of the activities referred to in Article 16(2)(a) and (b) of Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR)\/ Regulation (EU) 2017\/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR), they must inform the ANMDMR of placing the relabeled or repackaged device on the market, in accordance with the provisions of Article 12 of Order of the Minister of Health no. 3539\/2022 and Order of the Minister of Health no. 3753\/2023, respectively.<br \/>\nThe distributor or importer must submit to the ANMDMR a certificate, issued by a notified body designated for the type of devices subject to the activities referred to in Article 16(2)(a) and (b) of the MDR\/IVDR, attesting that the distributor\u2019s or importer\u2019s quality management system complies with the requirements set out in Article 16 paragraph (3) of the MDR\/IVDR.<br \/>\nThus, we hereby inform you that only certificates issued by notified bodies, which contain all the information corresponding to the requirements indicated in MDCG 2021- 23 \u201cGuidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017\/745 and Regulation (EU) 2017\/746\u201d are accepted.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/mdcg_2021-23_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-29-08-2025-3\/\">Important notification<\/a><div class=\"content\"><p><strong>29.08.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all interested parties<\/strong><\/span><br \/>\nAccording to the information received by the ANMDMR, counterfeit medical devices originating from a distributor in China have been identified on the Vietnamese market.<br \/>\nThe discrepancies identified by manufacturer Thermoplastic Comfort Systems, Inc., USA in the counterfeit TCS Unbreakable Dental Resin medical devices consist of:<br \/>\n1. The presence of the CE marking on the label, followed by the number of the Notified Body \u201cNational Standards Authority of Ireland, Ireland\u201d (0050), while the original medical devices are classified as class I and contain only the CE marking on the label.<br \/>\n2. The entire label, packaging configuration and information distribution differ from the original medical devices.<br \/>\n3. The label of the counterfeit medical devices was copied from previous versions of the label of the original medical devices, when the product required the involvement of a notified body in view of being placed on the market, and the CE marking followed by the notified body number was on the label.<br \/>\n<strong>If you have come into possession of counterfeit medical devices of the type mentioned above or if you are aware of distributors selling such devices on the Romanian territory, do not use them and notify the National Agency for Medicines and Medical Devices of Romania at the contact details posted on the ANMDMR website.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-04-08-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>04.08.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all interested parties<\/strong><\/span><br \/>\nThe NAMMDR was informed about the presence on the territory of Portugal of a falsified product composed of OZEMPIC 1 mg, Batch NF63704 and the medical device AC Novofine Plus 32G 4mm, Batch NE61324-2.<br \/>\nAccording to the manufacturer Novo Nordisk A\/S, Denmark, those Novofine Plus 32g 4mm from the original batch have other manufacturing and expiration dates, as follows:<br \/>\nThe <strong>NE61324-2 original batch<\/strong> was manufactured on 29.04.2023 and expires on 31.03.2028.<br \/>\nThe <strong>NE61324-2 falsified batch<\/strong> was manufactured on 04.2024 and expires on 03.2029.<br \/>\n<strong>In case you have been in possession of such falsified products, do not use them and notify the National Agency for Medicines and Medical Devices of Romania at the contact details posted on the NAMMDR website.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-01-08-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>01.08.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all interested persons<\/strong><\/span><br \/>\nThe NAMMDR warns of the withdrawal of the EC certification for Los Deline &#8211; hydrophilic gel for the process of using implants (endoprostheses) of the soft tissues of the human body, Biotr producer S.R.O., the Czech Republic. This medical device is an injectable, non-absorbable product, based on Copoliamide, used mainly for aesthetic purposes, to increase body volume, breasts and buttocks.<br \/>\nWithdrawal of the EC certification was decided by the notified body on 02.05.2023, following the unsatisfactory results of an intracutaneous reactivity test.<br \/>\nAccording to the information received by the NAMMDR, after the certificates withdrawal, by field safety notification FSN-23-002-pr, the manufacturer Biotrh S.R.O., the Czech Republic requested the withdrawal of all Los Deline 100g which remained unused, which were supposedly still present in the following states: Germany, Germany, Germany, Italy, Greece, Turkey, Switzerland, Cyprus, France and Norway.<br \/>\n<strong>The deadline for withdrawal of these devices from the EU was 30 November 2023, but given the validity period of these devices (3 years) and the fact that they were also marketed in non-EU countries, from where they can enter the EU territory, the NAMMDR recommends both healthcare professionals and patients to be extremely cautious and, if they have come into possession of such devices or are aware of distributors who sell these products on Romanian territory, to not use them and notify the National Agency for Medicines and Medical Devices of Romania &#8211; the market surveillance service at the contact details posted on the NAMMDR website.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-31-07-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>31.07.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of Romanian manufacturers of medical devices and in vitro diagnostic medical devices and all interested parties<\/strong><\/span><br \/>\nIn line with the COMMISSION IMPLEMENTING DECISION (EU) 2019\/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices, renewed for a five-year period, from 27 June 27 2024 to 27 June 2029 in line with the Commission Implementing Decision (EU) 2024\/2120 of 30 July 2024 renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices, the following organizations were officially recognized by the European Commission as UDI-issuing entities:<br \/>\n\u2013 GS1 AISBL,<br \/>\n\u2013 Health Industry Business Communications Council (HIBCC)<br \/>\n\u2013 ICCBBA<br \/>\n\u2013 Informationsstelle f\u00fcr Arzneispezialit\u00e4ten \u2014 IFA GmbH<br \/>\nThese decisions have been published in the Official Journal of the European Union.<br \/>\nThus, we inform you that only these 4 entities are designated by the Commission and can issue the UDI.<br \/>\nIf you have contracted another organization apart from the 4 listed above for issuing the unique device identifier of a device (&#8220;UDI system&#8221;) or if you are aware of such organizations which claim to be issuing UDI, you need to notify the National Agency for Medicines and Medical Devices of Romania &#8211; the Regulatory Directorate, Market Supervision (<a href=\"mailto:dgdm@anm.ro\">dgdm@anm.ro<\/a> and <a href=\"mailto:drsp@anm.ro\">drsp@anm.ro<\/a>), using the contact data available on the NAMMDR website.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-04-07-2025-2\/\">Important notification<\/a><div class=\"content\"><p><strong>04.07.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of Romanian manufacturers of medical devices and in vitro diagnostic medical devices and all interested parties<\/strong><\/span><br \/>\nWe inform you that starting with 26 May 2025, all the manufacturers of medical devices, regardless of the risk class of the medical device, have the obligation to apply the UDI support on the label of medical devices and on all outer layers of the packaging, in line with Article 123 (3) (f) and Article 27 (4) of the MDR.<br \/>\nMoreover, this obligation also applies to all manufacturers of in vitro diagnostic medical devices in the risk classes B, C, D according to Article 113 (3) (e) and Article 24 (4) of the IVDR.<br \/>\nFor in vitro diagnostic medical devices in the risk class A, the imprinting of the UDI support on the label is mandatory starting with 26 May 2027.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-04-07-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>04.07.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR was informed about the confiscation by the Customs authorities of Sweden of some counterfeit medical devices, belonging to batches A6108 (expiration date 12\/2026) and A00203 (expiration date 04\/04\/2027).<br \/>\nThe manufacturer of the original Sculptra, Poly-L-Lactic Acid, Q-MED AB Galderma, Sweden has confirmed that both batches are counterfeit, and batch A00203 is a recurrent one.<br \/>\nAccording to the checks carried out by the competent authority for medical devices in Sweden, the counterfeit Sculptra vials are marked with CE 0344, do not contain the PLLA (Poly-L-Lactic Acid), the main ingredient in the original Sculptra devices and contain glucose, an ingredient which is not found in the original Sculptra devices.<br \/>\nSculptra, Poly-L-lactic acid is a biostimulator used to correct skin depressions (cuts, wrinkles, folds, scars) and for skin aging, as well as for high volume corrections, in case of loss of facial fat (lipodistrophy).<br \/>\n<strong>If you have come into possession of the medical devices belonging to counterfeit batches A6108 (expiration date 12\/2026) and A00203 (expiration date 04\/04\/2027) or if you know distributors who sell such devices on Romanian territory, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service, using the contact data available on the NAMMDR website.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-25-06-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>25.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers of medical devices residing in Romania<\/strong><\/span><br \/>\n<strong>We hereby inform you that the Romanian manufacturers, notifying medical devices to the NAMMDR for registration into the national database in accordance with<em> Order of the Minister of Health no. 3.539\/2022 on approval of the Methodological rules for placement on the market of medical devices and registration of economic operators into the European database on medical devices (EUDAMED), as well as into the national database, and on waiver from compliance assessment procedures\u00a0<\/em><\/strong>or with <strong><em>Order of the Minister of Health no. 2.845 of 29 September 2022 on approval of the Methodological rules for approval of provisions of Article 13 of Emergency Government Ordinance no. 46\/2021 on the establishment of the institutional framework and the measures necessary to ensure the direct application of the provisions of Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) no. 178\/2002 and Regulation (EC) no. 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC, on registration of custom-made devices placed on the market under their own name by manufacturers based in Romania,\u00a0<\/em>must submit in the documentation related to the request the registration certificate at the<\/strong> <strong>National Trade Register Office (ONRC) and a certificate attesting the authorisation of the manufacturing of the medical devices, by indicating the CAEN code (rev.3), specific to the type of the notified medical device.<\/strong><\/p>\n<p><strong>Examples:<\/strong><\/p>\n<p><strong><em>CAEN 3250, Manufacture of devices, devices and dental tools for:<\/em><\/strong><\/p>\n<ul>\n<li>manufacture of surgical cloths and catgut,<\/li>\n<li>manufacture of distillate devices and laboratory centrifuges,<\/li>\n<li>manufacture of medical, surgical, dental furniture,<\/li>\n<li>manufacture of ophthalmic articles, eyeglasses, polished lenses according to the recipe, contact lenses,<\/li>\n<li>manufacture of disposable protective masks (surgical masks, FFP2, FFP3 masks, etc.)<\/li>\n<\/ul>\n<p><strong><em>CAEN 2120, <\/em><\/strong><strong><em>Manufacturing of pharmaceutical preparations<\/em><\/strong><\/p>\n<ul>\n<li>medical diagnosis preparations, including pregnancy tests,<\/li>\n<li>Radioactive tracers for in vivo clinical diagnosis,<\/li>\n<li>cotton wool, gauze, cloth, impregnated medicinal bandages, surgical catgut, etc.<\/li>\n<li>ultrasound medical equipment,<\/li>\n<li>electrocardiographs,<\/li>\n<li>endoscopic medical equipment<\/li>\n<\/ul>\n<p><strong><em>CAEN 2660, Manufacture of equipment for radiology, electrodiagnostic and electrotherapy<\/em><\/strong><\/p>\n<p><strong><em>CAEN 6210, Activities related to set up of the software on command<\/em><\/strong><\/p>\n<p>Software set up &#8211; medical device<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-16-06-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>16.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR was informed about a theft which occurred in Belgium on 10 April 2025, involving a truck carrying Juvederm from Pringy, France to Roermond, the Netherlands. The investigation discovered that 25 out of 26 pallets were stolen.<br \/>\nAll stocks remaining at the manufacturer AbbVie, France of the affected batches, as well as all remaining devices in the truck, which have not been stolen, shall be destroyed.<\/p>\n<p>Medical devices and affected batches:<\/p>\n<table>\n<tbody>\n<tr>\n<td valign=\"top\"><strong>Product code<\/strong><\/td>\n<td valign=\"top\"><strong>PRODUCT<\/strong><\/td>\n<td valign=\"top\"><strong>BATCH<\/strong><\/td>\n<td valign=\"top\"><strong>Quantity<\/strong><\/td>\n<td valign=\"top\"><strong>Affected markets<\/strong><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\">20076422<\/td>\n<td valign=\"top\">Juv\u00e9derm VOLUX<\/td>\n<td valign=\"top\">1003645951<\/td>\n<td valign=\"top\">4.513<\/td>\n<td valign=\"top\">Dedicated reference number for China<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\">94151JA<\/td>\n<td valign=\"top\">Juv\u00e9derm Vista VOLUMA XC<\/td>\n<td valign=\"top\">1003583816<\/td>\n<td valign=\"top\">4.954<\/td>\n<td valign=\"top\">Dedicated reference number for Japan<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\">94506KO<\/td>\n<td valign=\"top\">Juvederm VOLUMA cu Lidocain\u0103<\/td>\n<td valign=\"top\">1003598746<\/p>\n<p>1003598748<\/td>\n<td valign=\"top\">8.572<\/p>\n<p>7.095<\/td>\n<td valign=\"top\">Dedicated reference number for South Korea<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\">96637JR<\/td>\n<td valign=\"top\">Juvederm VOLUMA cu Lidocain\u0103<\/td>\n<td valign=\"top\">1003598743<\/td>\n<td valign=\"top\">6.311<\/td>\n<td valign=\"top\">Common reference number for EU countries and planned for delivery to Germany, Italy, Austria and Switzerland (multilingual package)<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\">20073835<\/td>\n<td valign=\"top\">SKINVIVE by Juvederm 2*1mL<\/td>\n<td valign=\"top\">1003543583<\/td>\n<td valign=\"top\">4.221<\/td>\n<td valign=\"top\">Reference number dedicated to India<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\">96180II<\/td>\n<td valign=\"top\">PF Juvederm Volbella w\/lidocaine 32G<\/td>\n<td valign=\"top\">1003645893<\/td>\n<td valign=\"top\">919<\/td>\n<td valign=\"top\">Reference number dedicated to India<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\">96666JR<\/td>\n<td valign=\"top\">JUVEDERM ULTRA 3 2*1.0mL<\/td>\n<td valign=\"top\">1003636606<\/td>\n<td valign=\"top\">5.268<\/td>\n<td valign=\"top\">Common reference number for EU countries and planned for delivery to Germany, Italy, Austria and Switzerland (multilingual package)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>If you have come into possession of medical devices such as the above mentioned or if you are aware of distributors who sell such devices on the Romanian territory, do not use them and notify the National Agency for Medicines and Medical Devices of Romania-The market surveillance service at the contact details posted on the NAMMDR website.<\/strong>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-03-06-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>03.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\n<strong>List of Training Suppliers concerning legislation in the field of medical devices, agreed by the NAMMDR<\/strong><br \/>\nIn line with the Rules, in order to obtain the operation permit, the economic operator must have sufficient and qualified\/trained staff for the activity he carries out\/the field in which he operates.<br \/>\nThe person responsible for compliance with the regulations (PRCR) specific to the field of medical devices and the head of the warehouse must be able to prove participation in training courses in the field of medical devices.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/AVIZE\/Lista lectori actualizata 03 iun 2025.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">descarc\u0103 documentul<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-20-03-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>20.03.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare institutions<\/strong><\/span><br \/>\n<em>On 27 February 2025, Part I, Order of the Minister of Health No. 650 was published, in the Official Gazette of Romania, Part I, on approval of the procedural rules for the application of the provisions of Art. 5 (5) of Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, of Regulation (EC) no. 178\/2002 and Regulation (EC) no. 1.223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC of the Council on medical devices and in vitro diagnostic medical devices manufactured and used only within healthcare institutions.<\/em><br \/>\nThis Order regulates the aspects regarding the manufacture and use of medical devices \/ in vitro diagnostic medical devices within healthcare institutions as well as the aspects regarding the notification of the use of such devices to the NAMMDR. The regulatory document is available online, in the section Medical Devices\/ Legislation\/Orders of the Minister of Health.<br \/>\nThe form used for the notification of the manufacture and use of such medical devices can be found in the section &#8220;Medical\/Forms and fees&#8221; coded as F.MD\/IVD_IS. Please be advised that the analysis of the notification and the related file is an Order of the Minister of Health tariff activity no. 3.467\/17.11.2022 on approval of the tariffs for the activities carried out by the National Agency for Medicines and Medical Devices of Romania (NAMMDR) in the field of medical devices, with the amount of indexed tariffs 2025.<br \/>\nThe payment form related to this activity can be found in the section &#8220;Medical \/ forms and fees&#8221;, named <strong>&#8220;Form for payment of the tariff &#8211; Evaluation File of notification of medical devices manufactured and used within public or private healthcare units \/ evaluation of the File for notification of a modification of medical devices used within public or private healthcare units&#8221;<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-10-03-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>10.03.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of users and distributors of devices for glucose monitoring<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices of Romania warns users and distributors of medical devices on increasing the number of misleading advertisements that appear on social media platforms (e.g. Facebook, Instagram, Tiktok) but also on some websites, advertisements that require the existence on the market of some glycaemia monitoring devices (glucose). These misleading advertisements on the Internet promote questionable non-invasive blood sugar (glucometer) glucose monitoring devices, including: painless and non-invasive glucometer; complete monitoring without stinging, new-generation multifunctional glucometer; complete monitoring of the state, multifunctional glucometer; non-invasive laser measuring device; non-invasive high-precision glucometer; non -invasive glucometer; premium non-invasive medical device etc.<br \/>\nTo all interested persons: please be advised that in order to enhance the credibility, in order to scam vulnerable people and to market questionable non-invasive blood glucose monitoring devices (glucometers), misleading statements regarding the origins of the products are used, these being promoted as belonging to renowned manufacturers in the field of medical devices.<br \/>\nThe National Agency for Medicines and Medical Devices of Romania recommends all interested parties, before any acquisition, to verify information about the medical devices from trusted sources and, in case of identifying misleading advertisements, not to access the links, not to distribute or buy the products promoted in such advertisements.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-25-02-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>25.02.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of users and distributors of devices monitoring vital functions for patients, Contec CMS8000 and Epsimed MN-120<\/strong><\/span><br \/>\nFollowing the signalling by cyber security authorities of possible critical backdoor vulnerabilities, that is, accessing the device by an attacker and loading or modifying the files stored on it, endangering data security and system integrity, the National Agency for Medicines and Medical Devices of Romania recommends:<br \/>\n&#8211; avoiding the connection of these medical devices to the Internet network;<br \/>\n&#8211; permanent monitoring of network traffic to identify signs of suspicious activities &#8211; if you keep the device connected to the Internet;<br \/>\n&#8211; Emergency transmission to the NAMMDR of any abnormal functioning signals, such as inconsistencies between the patient&#8217;s vital functions and its real physical condition, by filling in the Form for reporting serious incidents suspected in relation to medical devices or in vitro diagnostic medical devices &#8211; for healthcare professionals, users and patients (<a href=\"https:\/\/www.anm.ro\/dispozitive-medicale\/raporteaza-un-incident\/\" target=\"_blank\">https:\/\/www.anm.ro\/dispozitive-medicale\/raporteaza-un-incident\/<\/a>).<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-23-01-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>23.01.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all economic operators<\/strong><\/span><br \/>\nWe inform you that starting with January 2025 the tariffs for the activities carried out by the National Agency for Medicines and Medical Devices of Romania in the field of medical devices have been indexed with the average inflation rate of 2024 and can be found in Annex 1, hereby attached.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/Tarife%20DGDM%20indexate%202025.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">descarc\u0103 documentul<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-09-01-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>09.01.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe European Commission posted two public consultation for economic operators (manufacturers, authorised representatives, importers or distributors) on its website (<a href=\"https:\/\/ec.europa.eu\/eusurvey\/runner\/2024MDAvailabilityMFARIMDBsurvey\" target=\"_blank\">https:\/\/ec.europa.eu\/eusurvey\/runner\/2024MDAvailabilityMFARIMDBsurvey<\/a>) regarding medical devices and in vitro diagnostic medical devices within the trial monitoring the availability of medical devices on the European Union market (HaDEA\/2021\/P3\/03).<br \/>\nMore information on participation, confidentiality and other details related to this trial are available at: <a href=\"https:\/\/health.ec.europa.eu\/study-supporting-monitoring-availability-medical-devices-eu-market_en\" target=\"_blank\">https:\/\/health.ec.europa.eu\/study-supporting-monitoring-availability-medical-devices-eu-market_en<\/a> and <a href=\"https:\/\/ppri.goeg.at\/Study_MD_Availability\" target=\"_blank\">https:\/\/ppri.goeg.at\/Study_MD_Availability<\/a>.<br \/>\nDeadline for participation: <strong>28 February 2025<\/strong>.<br \/>\nThe purpose of this trial is to collect information about the transition of devices to EU regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). The questionnaire also contains questions regarding the undergoing targeted assessment, carried out by the European Commission. The first public consultation has provided essential data and the results are accessible using an interactive tool and as a PPT presentation.<br \/>\nThe trial is led by Gesundheit \u00d6sterreich GmbH (G\u00f6g), the Austrian National Public Health Institute, in collaboration with Aret\u00e9 and CivicConsulting and committed by the European Commission \u2013 the Directorate-General for Health &#038; Food Safety (DG SANTE) through the European Health and Digital Executive Agency (HaDEA).<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-23-12-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>23.12.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nConsidering the approval of <strong>Order of the Minister of Health no. 5930 of 11.12.2024 regarding the amendment and supplementation of the Annex to Order of the Ministry of Health. 194\/2015 on Rules for assessment and approval of advertising of medicinal products for human use, please be advised that the way of transmitting the Forms for declaration of sponsorship activities has been changed:<\/strong><br \/>\n<strong>Article 35, paragraphs (5) and (7) are amended and shall read as follows:<\/strong><br \/>\n&#8220;(5) The declaration of sponsorship activities, as well as of other expenses, other than sponsorship related, carried out under the conditions of paragraph (3) and (4) shall be made according to the forms whose template is provided in Annexes 1 and 2, <strong><u>by electronic signature according to the provisions of Art. 3 points 11 and 12 of Regulation (EU) no. 910\/2014, through online applications which can be accessed on the NAMMDR portal: portal.anm.ro.\u201d<\/u><br \/>\nPlease employ this manner of transmitting the declaration forms, which is the only way of transmitting the forms to the NAMMDR, in line with the legal provisions.<\/strong><br \/>\nPrior to filling in and transmitting the forms for declaration of sponsorship activities, please consult the completion guide for both sponsors and beneficiaries.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-17-12-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>17.12.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe European Commission launched on its website (<a href=\"https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/14155-EU-rules-on-medical-devices-and-in-vitro-diagnostics-targeted-evaluation_en\" target=\"_blank\">https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/14155-EU-rules-on-medical-devices-and-in-vitro-diagnostics-targeted-evaluation_en<\/a>) a request for participation in public consultation for the purpose of targeted assessment of EU regulations for medical devices and in vitro diagnostic medical devices.<br \/>\nThe results of the consultation will contribute to the evaluation of:<br \/>\n\u2022 the efficiency, effectiveness and proportionality<br \/>\n\u2022 meeting current and emerging needs<br \/>\n\u2022 the alignment with other European actions<br \/>\n\u2022 the added value at EU level of MDR and IVDR regulations.<br \/>\nAt the same time, the European Commission has intensified its efforts to provide the necessary implementation tools.<br \/>\nThe most recent updates and completions of the framework required for MDR and IVDR implementation are posted on <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations_en\" target=\"_blank\">https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations_en<\/a>: regulations for the application of MDR and IVDR, guides and brochures for all interested parties, for clarification and support in the correct understanding and enforcement of legal provisions, as well as links to templates of documents imposed by the legislation and prepared by European professional associations in the field for manufacturers and other dedicated market actors:<br \/>\n\u2022\t<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/dfd7a1c6-f319-4682-9bac-77bef1165818_en?filename=mdr_qna-ext-ivdr.pdf\" target=\"_blank\">Q&#038;A Extension of the IVDR transitional periods<\/a><br \/>\n\u2022\tTemplates for the IVD manufacturer statement during the transition period on the <a href=\"https:\/\/www.medtecheurope.org\/resource-library\/manufacturers-declaration-in-relation-to-regulation-eu-2024-1860\/\" target=\"_blank\">MedTech Europe<\/a> website<br \/>\n\u2022\tTemplate for written agreement and issued by a notified body (<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/70442a8a-cee3-4976-bd83-a8ea7fc1d49c_en?filename=md_confirmation-letter-2024-1860-nbcg.docx\" target=\"_blank\">Template for notified body confirmation letter endorsed by NBCG-Med<\/a>)<br \/>\n\u2022\t<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/b431b10f-8512-4f47-9191-e1b84b2f9a27_en?filename=mdr_qna-article10a_mdr-ivdr_en.pdf\" target=\"_blank\">Q&#038;A Obligation to inform in case of interruption or discontinuation of supply<\/a><br \/>\n\u2022\tThe form for reporting an interruption or termination of the manufacturing process of a medical device (<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/919061d9-5dfa-4d0b-ab9b-3543eed98f76_en?filename=md_mdc-2024-16_en.pdf\" target=\"_blank\">MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices<\/a>)<br \/>\n\u2022\tDevice identification table (<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/b4a7dea7-ae73-4e13-a8a8-11dcd2678d38_en?filename=md_mdc-2024-16_annex_en.pdf\" target=\"_blank\">MDCG 2024-16 Annex: Device Identification table<\/a>)<br \/>\nWe also invite you to consult the page dedicated to guidelines (orientation documents) for the implementation of MDR and IVDR (<a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en\" target=\"_blank\">https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en)<\/a>, which have recently been updated by the MDCG) and especially those for:<br \/>\n\u2022 Applying the provisions of MDR legacy devices: MDCG 2021-25 Rev.1, Application of MDR Requirements to &#8220;Legacy Devices&#8221; and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90\/385\/EEC or 93\/42\/EEC (<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en?filename=md_mdcg_2021_25_en.pdf\" target=\"_blank\">https:\/\/health.ec.europa.eu\/document\/download\/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en?filename=md_mdcg_2021_25_en.pdf<\/a>)<br \/>\n\u2022 Guidance on qualification of in vitro diagnostic medical devices 2024-11 (<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf\" target=\"_blank\">https:\/\/health.ec.europa.eu\/document\/download\/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf<\/a>)<br \/>\n\u2022 MDCG 2024-14, Guidance on the implementation of the Master UDI-DI solution for contact lenses (<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf\" target=\"_blank\">https:\/\/health.ec.europa.eu\/document\/download\/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf<\/a>)<br \/>\n\u2022 Regulation requirements for ethylene oxide, MDCG 2024-13, Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices (<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/3fa74c6b-953a-41f5-b024-8889ac8b5ddf_en?filename=mdcg_2024-13_en.pdf\" target=\"_blank\">https:\/\/health.ec.europa.eu\/document\/download\/3fa74c6b-953a-41f5-b024-8889ac8b5ddf_en?filename=mdcg_2024-13_en.pdf<\/a>)<br \/>\n\u2022 Borderline between medical devices and medicinal products, MDCG 2022-5 rev.1, Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017\/745 on medical devices (<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en.pdf\" target=\"_blank\">https:\/\/health.ec.europa.eu\/document\/download\/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en.pdf<\/a>)<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-12-11-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>12.11.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of economic operators approved by the National Agency for Medicines and Medical Devices of Romania who carry out activities in the field of medical devices<\/strong><\/span><br \/>\nIn line with Order of the Minister of Health no. 566\/2020 on approval of the Methodological rules for application of Title XX of Law 95\/2006 on healthcare reform, the marketing activities and the activities related to the provision of services in the field of medical devices subject to control by approval are the following:<br \/>\na) the import of medical devices;<br \/>\nb) the distribution of medical devices;<br \/>\nc) the installation and\/or maintenance of medical devices.<br \/>\nThe operation permit issued in accordance with Order of the Minister of Health no. 566\/2020 is valid for a 3-year period from the date of issuance, if the conditions on which the permit was issued remain unchanged. The validity of this permit ceases on the date of issuance of the new operation permit.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-01-11-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>01.11.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers and all interested stakeholders<\/strong><\/span><br \/>\nPlease be informed that on 30.10.2024, the European Commission published the Questions and Answers Guideline (Q&#038;A) on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024\/1860 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices, as introduced by Regulation (EU) 2024\/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.<br \/>\nThe document is available here:<br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/b431b10f-8512-4f47-9191-e1b84b2f9a27_en?filename=mdr_qna-article10a_mdr-ivdr_en.pdf\" target=\"_blank\">https:\/\/health.ec.europa.eu\/document\/download\/b431b10f-8512-4f47-9191-e1b84b2f9a27_en?filename=mdr_qna-article10a_mdr-ivdr_en.pdf<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/mdr_qna-article10a_mdr-ivdr_en.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-24-10-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>24.10.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of professional users of medical devices<\/strong><\/span><br \/>\nWe inform you that starting with 24.10.2024, the provisions of <strong>Art. 933 (1) l) of Law 95\/2006<\/strong> enter into force, namely:<br \/>\n<em>Art. 933 \u2013 (1) In order to ensure the level of security and performance appropriate to the purpose for which the medical devices are made and to avoid potential incidents, users are obliged to:<br \/>\nk) to ensure that they only use medical devices when, in the course of their professional activities, they use equipment for the purpose of diagnosing, preventing, monitoring, predicting, prognosticating, treating or alleviating a disease, as defined in Article 2, point 1, first indent of Regulation (EU) 2017\/745;<br \/>\nl)*) to comply with the provisions of point k) for medical devices put into operation and in use prior to the entry into force of the deadline provided for in Art. V paragraph (3) of Government Ordinance no. 37\/2022 on amendment and supplementation of Law No. 95\/2006 on healthcare reform and of Law No. 227\/2015 regarding the Fiscal code, and on establishment of other measures in the healthcare field, approved as amended and supplemented through Law no. 328\/2022.<\/em><br \/>\n_____________<br \/>\n*)\u00a0<strong>The provisions of point l), introduced by Emergency Ordinance no. 88\/2023, enter into force on 24 October 2024<\/strong> (see Art. IX paragraph (1) point c) of Emergency Ordinance no. 88\/2023)<\/p>\n<p>The NAMMDR, as the competent authority in the field of medical devices, supervises and controls whether the requirements of the legal regulations are observed, through thematic controls. These controls shall be carried out both on economic operators who import, sell\/distribute and perform activities in the field of medical devices and on professional users who use them.<br \/>\nThus, within the controls that will be carried out by the NAMMDR on professional users of medical devices, it shall be verified whether there are only medical devices used within the professional activity of diagnosis, prevention, monitoring, prediction, prognosis, treatment or improvement of a disease.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-18-10-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>18.10.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nStarting with <strong>21.10.2024, the activity of registration and issuance of documents, including for the General Directorate of Medical Devices<\/strong>, shall be carried out only at the headquarters of the National Agency for Medicines and Medical Devices of Romania, at 48 Aviator S\u0103n\u0103tescu Street, Sector 1, Bucharest.<\/p>\n<p><strong>Working hours<\/strong>:<br \/>\nMONDAY \u2013 THURSDAY: 9:00 \u2013 15:00<br \/>\nFRIDAY \u2013 9:00 \u2013 13:00<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-13-08-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>13.08.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of professional users who work or are employed in healthcare facilities<\/strong><\/span><br \/>\nThe European Commission is currently considering the possibility of allowing the use of electronic instructions for use (eIFU) for all devices for professional use (those used by healthcare professionals). To this end, it has launched a survey on the use of eIFU for medical devices, which are specifically used by healthcare professionals and other professional users working or employed in a healthcare institution of the European Union. The deadline for accessing the questionnaire is 11 October 2024.<br \/>\nPlease visit the link of the survey here: <a href=\"https:\/\/ec.europa.eu\/eusurvey\/runner\/Survey_eIFUs_medicaldevices_2024\" target=\"_blank\">https:\/\/ec.europa.eu\/eusurvey\/runner\/Survey_eIFUs_medicaldevices_2024<\/a><br \/>\nas well as the survey in Romanian:<br \/>\n<a href=\"https:\/\/ec.europa.eu\/eusurvey\/runner\/Survey_eIFUs_medicaldevices_2024?surveylanguage=RO\" target=\"_blank\">https:\/\/ec.europa.eu\/eusurvey\/runner\/Survey_eIFUs_medicaldevices_2024?surveylanguage=RO<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-17-07-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>17.07.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nAnnouncement regarding professional training and instruction courses for staff with specific duties of installation and\/or maintenance of medical devices<br \/>\nAccording to the provisions of Order No. 566\/2020 on approval of the Methodological rules for application of Title XX of Law 95\/2006 on healthcare reform, regarding the approval of activities in the field of medical devices, professional training and instruction courses can be provided by the trained technical staff:<br \/>\na) of a manufacturer\/representative of a manufacturer;<br \/>\nb) of professional associations in the field of medical devices;<br \/>\nc) of economic operators approved by the NAMMDR, if their object of activity is the conduct of training courses.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/Anunt%20instruire%20Service%20iulie%202024.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-10-07-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>10.07.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all stakeholders<\/strong><\/span><br \/>\nWe inform you that on 9 July 2024, the European Commission published Regulation (EU) 2024\/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices (IVDs).<br \/>\nThe regulation provides for the acceleration of the launch and mandatory use of Eudamed for modules which are already available and functioning properly as of the end of 2025 \u2013 thus improving transparency, providing up-to-date information on devices on the EU market and contributing to the monitoring of device availability.<br \/>\nLikewise, it introduces an obligation for manufacturers to notify authorities, economic operators and\/or healthcare institutions in advance, in the event of interruptions in the supply of IVDs or medical devices which would pose a risk to patients before temporarily or permanently ceasing the supply of a vital device.<br \/>\nThe proposed new transition periods shall depend on the type of device, in particular its risk class, as established in line with Regulation (EU) 2017\/746 (IVDR):<br \/>\n\u2013 shorter transition period for high-risk IVDs, class D (31 December 2027)<br \/>\n\u2013 longer periods for medium- and low-risk IVDs, classes C and B (31 December 2028 and 31 December 2029 respectively).<br \/>\n\u2013 section Directives and regulations \u2013 Medical devices, the Regulation itself (file \u201cREGULATION (EU) 2024_1860 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL_RO_TXT.pdf\u201d).<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/REGULAMENTUL%20(UE)%202024_1860%20AL%20PARLAMENTULUI%20EUROPEAN%20%C8%98I%20AL%20CONSILIULUI_RO_TXT.pdf\" rel=\"noopener\" target=\"_blank\">download Regulation &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/Ghid%20de%20%C3%8Entreb%C4%83ri&#038;R%C4%83spunsuri%20privind%20aspecte%20practice%20legate%20de%20punerea%20%C3%AEn%20aplicare%20a%20Regulamentului%20(UE)%202024_1860.pdf\" rel=\"noopener\" target=\"_blank\">download the Questions &#038; Answers Guide on practical aspects related to the implementation of Regulation (EU) 2024_1860 &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/Ghid%20de%20%C3%8Entreb%C4%83ri&#038;R%C4%83spunsuri%20privind%20aspecte%20practice%20legate%20de%20punerea%20%C3%AEn%20aplicare%20a%20Regulamentului%20(UE)%202024_745_rev.2.pdf\" rel=\"noopener\" target=\"_blank\">download the Questions and Answers Guide on practical aspects related to the implementation of Regulation (EU) 2024_745_rev.2 &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-22-04-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>22.04.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\n<strong>List of training providers of medical device legislation, approved by the NAMMDR<\/strong><br \/>\nIn line with the <strong>Rules<\/strong>, in order to obtain the operation permit, the economic operator must have sufficient and qualified\/trained staff for the activity it carries out\/the field in which it operates.<br \/>\nThe person responsible for compliance with the regulations (PRCR) specific to the field of medical devices and the warehouse manager must provide proof of participation in training courses on the subject of legislation in the field of medical devices.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/AVIZE\/Lista%20lectori%20actualizata%2019%20apr%202024.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-15-04-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>15.04.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all stakeholders (healthcare units, importers\/distributors, patients)<\/strong><\/span><br \/>\nAs of April 2024, a new SAFETY NOTICES section was created on the NAMMDR website, where, at the beginning of each month, the field safety notifications (Field Safety Notice \u2013 FSN) received by NAMMDR in the previous month shall be posted.<br \/>\nWe inform you that the first post on the website includes only the Summary of notifications regarding field safety for the period 18-29.03.2024, and starting in May, all notifications received by the NAMMDR during a month shall be posted.<br \/>\n<strong>If you have acquired a device affected by a field safety issue, please carefully read the associated field safety notice and follow the manufacturer&#8217;s instructions contained therein. For questions regarding the manufacturer&#8217;s instructions, please contact the issuer of the field safety notice directly.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-09-04-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>09.04.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nNotification regarding professional training and instruction courses for staff with specific duties of installing and\/or maintaining medical devices<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/Anunt%20instruire%20Service%20martie%202024_04.04.2024.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-08-03-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>08.03.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of economic operators \u2013 taxable persons established in Romania<\/strong><\/span><br \/>\nGiven the mandatory implementation of the RO e-Invoice system from 1 January 2024, according to the provisions of Art. LIX, paragraph (1) of Law 296\/2023, all invoices issued by the NAMMDR representing tariffs provided for in Order 888\/2014, respectively in Order 3467\/2022, will be sent only through the RO e-Invoice system, regardless of whether or not the recipients are registered in the RO e-Invoice Register.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-04-03-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>04.03.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of economic operators requesting issuance\/renewal of the operation permit<\/strong><\/span><br \/>\nIn this section, the National Agency for Medicines and Medical Devices of Romania (NAMMDR) provides you with the digital platform within the project &#8220;Service for issuing operation permits \/ renewing operation permits&#8221;. To access the platform, economic operators shall create their user account at: https:\/\/avizaredm.anmdm.ro\/login and follow the instructions in the user manual, available for download here. The entire approval process shall take place online through the digital platform, economic operators having access to the issued\/ renewed operation permit upon completion of the request.<br \/>\nWe hereby encourage all economic operators performing activities in the field of medical devices to create their user account, in order to be able to submit requests for issuance and renewal of operation permits.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/Manual%20de%20utilizare%20ANM%20-%20Beneficiar.pdf\" rel=\"noopener\" target=\"_blank\">download the user manual &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-06-02-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>06.02.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all economic operators<\/strong><\/span><br \/>\nWe would like to inform you that starting with January 2024, the tariffs for the activities carried out by the National Agency for Medicines and Medical Devices of Romania in the field of medical devices have been indexed with the average inflation rate of 2023 and can be found in Annex 1 attached to this notification.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/Anexa%201%20tarife%20ANMDMR-DM.pdf\" rel=\"noopener\" target=\"_blank\">document download &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-29-01-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>29.01.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all stakeholders<\/strong><\/span><br \/>\nPlease be informed that on 23 January 2024, the European Commission published a proposal to rectify Regulation (EU) 2017\/745, intended for medical devices (MDR) and Regulation (EU) 2017\/746, intended for in vitro diagnostic medical devices (IVDR).<br \/>\nThe proposal aims to:<br \/>\n\u2013 ensure the availability of in vitro diagnostic medical devices by giving manufacturers more time to adapt to the new rules, subject to certain important conditions;<br \/>\n\u2013 increase transparency and protect patient care by accelerating the launch of parts of the European database on medical devices \u2013 EUDAMED;<br \/>\n\u2013 to give healthcare systems more time to protect patient care, by requiring manufacturers to submit notifications, in the event of supply disruptions for certain medical devices and in vitro diagnostic medical devices.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/CELEX_52024PC0043_EN_TXT.pdf\" rel=\"noopener\" target=\"_blank\">document download &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-07-12-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>07.12.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of Romanian manufacturers of medical devices and in vitro diagnostic medical devices and authorised representatives<\/strong><\/span><br \/>\nWe inform you that on 1 December 2023, the European Commission published a study to monitor the availability of medical devices on the EU market. Please see the Questionnaires for MD and IVD manufacturers and authorised representatives.<br \/>\nThe notification can be found\/completed on the European Commission website by accessing the following link:<br \/>\n<a href=\"https:\/\/ec.europa.eu\/eusurvey\/runner\/MFandAR\" target=\"_blank\">https:\/\/ec.europa.eu\/eusurvey\/runner\/MFandAR<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-24-10-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>24.10.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare facilities and all interested parties<\/strong><\/span><br \/>\nFollowing the notification received from MEDTRONIC Romania SRL, regarding the submission by the company DEYAN KRAFT MEDICAL SRL of NAMMDR notice no. 112327E\/06.06.2023 within the procedures for solving appeals following an auction for blood glucose monitoring systems, in relation to these systems produced by MEDTRONIC MINIMED U.S., the NAMMDR conducted a verification in order to clarify the aspects related to the suitability of using these medical devices in diabetic paediatric patients under 14 years old.<br \/>\nThe verification targeted blood glucose monitoring systems manufactured by MEDTRONIC MINIMED U.S., including the Guardian sensor (3), which MEDTRONIC Romania SRL sells on the Romanian market, as an authorised distributor of MEDTRONIC MINIMED.<br \/>\nThe conclusions of the verification demonstrated that MEDTRONIC blood glucose monitoring systems sold on the Romanian market do not have age limits, being suitable for use by children under 14 years old.<br \/>\nThus, with respect to the NAMMDR viewpoint no. 112327E\/06.06.2023, we hereby make the following clarifications:<br \/>\nThe viewpoint expressed in the aforementioned NAMMDR notice refers to the document &#8220;System user Guide&#8221; presented in written format by DEYAN KRAFT MEDICAL S.R.L. together with the request, and which includes the Guardian Connect application (iOS: CSS7200, Android\u2122 , CSS7201), the Guardian Connect transmitter (MMT- 7821L), the Guardian Sensor (3) and their accessories.<br \/>\nThe document\u2019s version is 2018, valid in the United States of America and published on the official website of the manufacturer MEDTRONIC MINIMED US, on the page dedicated to users in the United States (automatically displayed when opening the webpage. Other locations can be selected on the corresponding button).<br \/>\nLink:<br \/>\n<a href=\"https:\/\/www.medtronicdiabetes.com\/sites\/default\/files\/library\/download-library\/user-guides\/guardian-connect-v3_2\/us-manual.pdf\" target=\"_blank\">https:\/\/www.medtronicdiabetes.com\/sites\/default\/files\/library\/download-library\/user-guides\/guardian-connect-v3_2\/us-manual.pdf<\/a><br \/>\nThe \u201dSystem user Guide\u201d:<br \/>\n\u2013 is intended for use as a system as a whole, the system including the three main components: the application, the transmitter and the sensor, as well as their accessories;<br \/>\n\u2013 does not bear the CE marking, applicable in the European space;<br \/>\n\u2013 the user manual complies with the legal requirements of the United States of America and, as a result, includes the age limits specified on page 2.<br \/>\nIn the European Economic Area, MEDTRONIC MINIMED markets these systems, in accordance with the European legislation in force at the time of the placement on the market, namely Directive 93\/42\/EEC.<br \/>\nThis device has been subject to conformity assessment procedures appropriate to the device\u2019s class, with the involvement of the notified body GMED France.<br \/>\nFollowing the certificate issued by the GMED, the manufacturer issued the declaration of conformity and affixed the CE marking. This marking is also found on the last page of the user manual together with the identification number of the notified body (CE 0459). The authorised representative in the European Union, namely MEDTRONIC B.V. of the Netherlands, is also specified.<br \/>\nOn the European market, including Romania, the system is sold with 3 manuals, for the main components, namely:<br \/>\n<strong>GuardianTM Connect<\/strong> \u2013 User Guide, with the Romanian version GuardianTM Connect \u2013 User Guide (for the transmitter);<br \/>\n<strong>GuardianTM Sensor (3)<\/strong> \u2013 User Guide (in several languages, including English and Romanian) (for the sensor).<br \/>\n<strong>GuardianTM Connect<\/strong> \u2013 Application User Guide (for the application).<br \/>\n<strong>These manuals do not indicate age limits for the components of the blood glucose monitoring system.<\/strong><br \/>\nBelow are the links to the user manuals, published on the MEDTRONIC Romania website:<br \/>\n<a href=\"https:\/\/resources.cloud.medtronic-diabetes.com\/sites\/prd\/files\/documents\/2022-03\/manual-guardian-connect-lock-out1.pdf\" target=\"_blank\">https:\/\/resources.cloud.medtronic-diabetes.com\/sites\/prd\/files\/documents\/2022-03\/manual-guardian-connect-lock-out1.pdf<\/a><br \/>\n<a href=\"https:\/\/resources.cloud.medtronic-diabetes.com\/sites\/prd\/files\/documents\/2022-03\/guardian-sensor-3-ifu.pdf\" target=\"_blank\">https:\/\/resources.cloud.medtronic-diabetes.com\/sites\/prd\/files\/documents\/2022-03\/guardian-sensor-3-ifu.pdf<\/a><br \/>\n<a href=\"https:\/\/resources.cloud.medtronic-diabetes.com\/sites\/prd\/files\/documents\/2022-03\/guardian-connect-aplicatie-32-lot-1.pdf\" target=\"_blank\">https:\/\/resources.cloud.medtronic-diabetes.com\/sites\/prd\/files\/documents\/2022-03\/guardian-connect-aplicatie-32-lot-1.pdf<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-16-10-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>16.10.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nNotification concerning professional training and instruction courses for staff with specific duties of installing and\/or maintaining medical devices<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/Anunt%20cursuri%20service%20actualizat%2016%20oct%202023.pdf\" rel=\"noopener\" target=\"_blank\">document download &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-06-10-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>06.10.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all interested parties<\/strong><\/span><br \/>\nPlease be informed that on 27 September 2023, the European Commission published the new version of the document Manual on borderline and classification for medical devices under Regulation (EU) 2017\/745 on medical devices and Regulation (EU) 2017\/746 on in vitro diagnostic medical devices.<br \/>\nNew products such as endovascular adhesives, sensors, irrigation solutions, customised implants and many more have been introduced.<br \/>\nThe European Commission notification is available at: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/manual-borderline-and-classification-community-regulatory-framework-medical-devices-september-2023-2023-09-27_en\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/manual-borderline-and-classification-community-regulatory-framework-medical-devices-september-2023-2023-09-27_en<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/md_borderline_manual_en.pdf\" rel=\"noopener\" target=\"_blank\">document download &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-04-10-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>04.10.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all interested parties<\/strong><\/span><br \/>\nWe hereby inform you that on 26 September 2023, the European Commission published the document Questions and Answers on transitional provisions for products without an intended medical purpose, covered by Annex XVI of the MDR.<br \/>\nThe European Commission notification is available at: <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-09\/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf\" target=\"_blank\">https:\/\/health.ec.europa.eu\/system\/files\/2023-09\/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf\" rel=\"noopener\" target=\"_blank\">document download &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-25-09-2023-2\/\">Important notification<\/a><div class=\"content\"><p><strong>25.09.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all stakeholders (importers\/distributors, users)<\/strong><\/span><br \/>\nFollowing a notification received and the checks carried out by the NAMMDR, we would like to warn all interested parties that counterfeit Durex condoms, BATCH 0010471127, were detected on the Romanian market, which were allegedly manufactured by the manufacturer Reckitt Benckiser Healthcare (UK) Limited, UK.<br \/>\n<strong>According to the manufacturer, this batch was manufactured only once, in 2011, with an expiration date of 2016-09, under the name Durex Fetherlite, and was delivered to Nigeria in packages of 3 pieces.<\/strong><br \/>\nWe warn interested parties not to import\/distribute or purchase, for the purpose of making available on the Romanian market or personal use, BATCH 0010471127 condoms of the DUREX brand, regardless of their name (model\/type), if they are within their expiration date, since these are counterfeit medical devices.<br \/>\nIf you are aware of importers\/distributors who have sold such counterfeit condoms on Romanian territory or if you have come into possession of such counterfeit condoms, please notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service, at <a href=\"mailto:sesizaridm@anm.ro\">sesizaridm@anm.ro<\/a> or at the other contact details available on the NAMMDR website.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-28-08-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>28.08.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all interested parties<\/strong><\/span><br \/>\nWe inform you that on 23 August 2023, the European Commission published the diagram with the conditions and deadlines for placing on the market or putting into service of &#8220;legacy&#8221; devices and custom-made implantable class III devices, in line with Article 120 of the MDR, as amended by Regulation 2023\/607.<br \/>\nThe flowchart is intended to help manufacturers and other relevant actors decide whether the device is covered by the extended transition period provided for in Article 120 of Regulation (EU) 2017\/745 on medical devices (MDR), as amended by Regulation 2023\/607.<br \/>\nThe flowchart should determine the eligibility, conditions and deadlines for placing on the market or putting into service of certain devices, in accordance with Article 120 of the MDR.<br \/>\nIt is also recommended to consult the text of the MDR, which takes precedence over the diagram, and the questions and answers on practical aspects related to the implementation of Regulation (EU) 2023\/607.<br \/>\nThe flowchart is split into two parts:<br \/>\nPart 1: Legacy devices referred to in Article 120(3a) of the MDR, i.e. devices covered by a certificate issued by a notified body, in line with Directive 90\/385\/EEC (AIMDD) or Directive 93\/42\/EEC (MDD) before 26 May 2021 and legacy devices referred to in Article 120(3b) of the MDR, i.e. devices for which the conformity assessment procedure, in accordance with Directive 93\/42\/EEC (MDD), did not require the involvement of a notified body, for which the declaration of conformity was drawn up before 26 May 2021 and for which the conformity assessment procedure in accordance with the MDR requires the involvement of a notified body.<br \/>\nPart 2: Class III custom-made implantable devices referred to in Article 120(3f) of the MDR.<br \/>\nThe notification can be downloaded from the European Commission website:<br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/flowchart-assist-deciding-whether-or-not-device-covered-extended-mdr-transitional-period-2023-08-23_en\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/flowchart-assist-deciding-whether-or-not-device-covered-extended-mdr-transitional-period-2023-08-23_en<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/md_devices-art120_flowchart.pdf\" rel=\"noopener\" target=\"_blank\">document download &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-21-08-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>21.08.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\n<strong>List of training providers on medical device legislation, approved by the NAMMDR<\/strong><br \/>\nIn line with the Rules, in order to obtain an operation permit, the economic operator must have sufficient and qualified\/trained staff for the activity it carries out\/the field in which it operates.<br \/>\nThe person responsible for compliance with the (PRCR) regulations specific to the medical device field and the warehouse manager must provide proof of participation in training courses on medical device legislation.<br \/>\nArt. 9 paragraph (3) of the Rules provides the following:<br \/>\n(3) The training courses shall be carried out by authorised individuals and legal entities whose object of activity is the provision of training provided for in paragraph (2) point b) and who provide proof of professional experience in regulatory activities or conformity assessment of medical devices, as follows:<br \/>\na) in regulatory activities with at least of a 4-year professional experience in the field of medical devices or participation in working groups specific to the field of medical devices at the level of the European Commission\/Council of the European Union;<br \/>\nb) in medical device conformity assessment activities within a notified conformity assessment body on the specific medical device directives, at least two years.<br \/>\nSince the appearance of Order of the Minister of Health 566\/2020, the NAMMDR has contacted companies that have issued diplomas\/certificates as a result of supporting training courses on the subject of medical device legislation and which we have found in the files submitted by economic operators, in order to approve the activity carried out. Based on the internal working procedure, as specified in Art. 7 of the Rules, evidence of compliance with the requirements of Art. 9 (3) was requested by the lecturers teaching these courses.<br \/>\nTo date, the companies having proven compliance with these requirements are the following:<\/p>\n<table>\n<tbody>\n<tr>\n<td>No.<\/td>\n<td>Legal person<\/td>\n<td>Lecturer&#8217;s name, surname<\/td>\n<\/tr>\n<tr>\n<td>1.<\/td>\n<td>MEDTECH CONSULTING SRL<\/td>\n<td>MARGARETA\u00a0 MIHALACHE<\/td>\n<\/tr>\n<tr>\n<td>2.<\/td>\n<td>MEDICAL DEVICE LEX SRL<\/td>\n<td>LAZ\u0102R IORDACHE<br \/>\nIOANA \u021aENE<\/td>\n<\/tr>\n<tr>\n<td>3.<\/td>\n<td>MEDIA KOMPASS SRL<\/td>\n<td>NICOLAE FOTIN<\/td>\n<\/tr>\n<tr>\n<td>4.<\/td>\n<td>CERTINSPECT REGISTER SRL<\/td>\n<td>GHEORGHE NEAGU<\/td>\n<\/tr>\n<tr>\n<td>5.<\/td>\n<td>ASOCIA\u021aIA DE STANDARDIZARE DIN ROM\u00c2NIA \u2013 ASRO<\/td>\n<td>MARGARETA\u00a0 MIHALACHE<\/td>\n<\/tr>\n<tr>\n<td>6.<\/td>\n<td>EUROASIA SRL<\/td>\n<td>CHRISTIAN HEINRICH<\/td>\n<\/tr>\n<tr>\n<td>7.<\/td>\n<td>OTD GLOBAL PRO SRL<\/td>\n<td>CHRISTIAN HEINRICH<\/td>\n<\/tr>\n<tr>\n<td>8.<\/td>\n<td>POPI INVEST CORP SRL<\/td>\n<td>GHEORGHE NEAGU<\/td>\n<\/tr>\n<tr>\n<td>9.<\/td>\n<td>MEDILEX TRAINING HUB SRL<\/td>\n<td>IOANA \u021aENE<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>When the list undergoes changes, we shall publish its revised version immediately. In this regard, please check the NAMMDR website permanently for updated information.<br \/>\nNOTE: The NAMMDR permanently monitors the activity of training providers. In this regard, if you are dissatisfied with the performance of training providers regarding the way the training is conducted or the quality of the services, you can report the negative aspects to <a href=\"mailto:da@anm.ro\">da@anm.ro<\/a> or <a href=\"mailto:dgdm@anm.ro\">dgdm@anm.ro<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-09-08-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>09.08.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all stakeholders<\/strong><\/span><br \/>\nNotification regarding professional training and training courses for staff with specific duties of installing and\/or maintaining medical devices<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/Anunt%20instruire%20Service_23.08.2023.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-27-07-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>27.07.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all interested stakeholders<\/strong><\/span><br \/>\nPlease be informed that the most recent update of the EU common list of COVID-19 antigen tests was published on 26.07.2023.<br \/>\nThis list is available online:<br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-07\/covid-19_eu-common-list-antigen-tests_en.pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/system\/files\/2023-07\/covid-19_eu-common-list-antigen-tests_en.pdf<\/a><br \/>\nIn the context of the COVID-19 pandemic, the Health Security Committee established in May 2021 a technical working group on COVID-19 diagnostic tests. This technical working group brought together experts from the 27 EU countries and Norway, as well as representatives from the Directorate-General for Health and Food Safety (DG SANTE), the Joint Research Centre (JRC) and the European Centre for Disease Prevention and Control (ECDC).<br \/>\nThe aim of the technical working group was, in particular, to review the proposals put forward by EU countries as well as manufacturers for devices to be included in the EU common list of COVID-19 antigen tests.<br \/>\nIn case the technical working group considered that an update of the EU common list of COVID-19 antigen tests was required, a proposal was presented to the Health Security Committee for formal agreement. Such updates concerned additions and\/or removals of antigen tests, or updates regarding the availability of data and information (e.g. the publication of new validation studies). An addendum was published alongside every update of the EU common list, setting out further details and background information regarding the decisions taken by the technical working group.<br \/>\nThis Annex is available online:<br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-07\/covid-19_eu-common-list-antigen-tests_addendum_en.pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/system\/files\/2023-07\/covid-19_eu-common-list-antigen-tests_addendum_en.pdf<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-24-07-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>24.07.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all interested stakeholders<\/strong><\/span><br \/>\nPlease be informed that on 18 July 2023 the European Commission has published the Q&#038;A on practical aspects related to the implementation of Regulation (EU) 2023\/607 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, REV. 1.<br \/>\nThe purpose of this Q &#038; A Guideline is to facilitate the enforcement of Regulation (EU) 2023\/607.<br \/>\nIn Rev. 1 of the guideline, new questions were added and some questions from the initially published guideline were modified\/supplemented.<br \/>\nThe announcement is available online on the website of the European Commission:<br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-07\/mdr_proposal_extension-q-n-a.pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/system\/files\/2023-07\/mdr_proposal_extension-q-n-a.pdf<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/mdr_proposal_extension-q-n-a.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-20-07-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>20.07.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\n<strong>List of training providers with the topic of legislation in the field of medical devices, approved by the NAMMDR<\/strong>. In line with the <strong>Rules<\/strong>, in order to obtain an operating permit, the economic operator must have sufficient and qualified\/trained staff for the activity carried out\/the field in which he\/she operates.<br \/>\nThe Medical Device Regulatory Compliance Officer (PRCR) and Warehouse Manager must demonstrate attendance at medical device legislation training courses.<br \/>\n<strong>Articles 9 (3) of the Rules<\/strong> provides:<br \/>\n(3) The training courses will be carried out by authorised physical and legal persons whose object of activity is to provide the training provided for in paragraph (2) b) and who provide proof of professional experience in regulatory or conformity assessment activities related to medical devices, as follows:<br \/>\na) in regulatory activities with professional experience of at least four years in the field of medical devices or participation in working groups specific to medical devices at European Commission\/EU council level;<br \/>\nb) in medical device compliance assessment activities within a notified compliance assessment body on the specific medical device directives, for at least two years.<br \/>\nSince issuance of Order of the Minister of Health no. 566\/2020, the NAMMDR has been so far in contact with the companies that issued diplomas\/certificates as a result of organising training courses about the medical devices legislation and which we have found in the dossiers submitted by economic operators in order to approve the activity carried out. According to the internal work procedure, as specified in Art. 7 of the Rules, evidence of meeting the requirements of Art. 9 (3) by the employed lecturers have been required in order to teach these training courses.<br \/>\nUp to this date, the companies that have proven that they comply with these requirements are as follows:<\/p>\n<table>\n<tbody>\n<tr>\n<td>No.<\/td>\n<td>Legal entity name<\/td>\n<td>Name and surname of the lecturer<\/td>\n<\/tr>\n<tr>\n<td>1.<\/td>\n<td>MEDTECH  CONSULTING  SRL<\/td>\n<td>MARGARETA\u00a0 MIHALACHE<\/td>\n<\/tr>\n<tr>\n<td>2.<\/td>\n<td>MEDICAL DEVICE LEX SRL<\/td>\n<td>LAZ\u0102R  IORDACHE<br \/>\nMARGARETA MIHALACHE\n<\/td>\n<\/tr>\n<tr>\n<td>3.<\/td>\n<td>MEDIA KOMPASS SRL<\/td>\n<td>NICOLAE FOTIN<\/td>\n<\/tr>\n<tr>\n<td>4.<\/td>\n<td>CERTINSPECT REGISTER SRL<\/td>\n<td>GHEORGHE NEAGU<\/td>\n<\/tr>\n<tr>\n<td>5.<\/td>\n<td>ASOCIA\u021aIA DE STANDARDIZARE DIN ROM\u00c2NIA \u2013 ASRO<\/td>\n<td>MARGARETA\u00a0 MIHALACHE<\/td>\n<\/tr>\n<tr>\n<td>6.<\/td>\n<td>EUROASIA SRL<\/td>\n<td>CHRISTIAN HEINRICH<\/td>\n<\/tr>\n<tr>\n<td>7.<\/td>\n<td>OTD GLOBAL PRO SRL<\/td>\n<td>CHRISTIAN HEINRICH<\/td>\n<\/tr>\n<tr>\n<td>8.<\/td>\n<td>POPI INVEST CORP SRL<\/td>\n<td>GHEORGHE NEAGU<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>When the list undergoes changes, we shall immediately post the revision. In this regard, please check the NAMMDR website regularly for updated information.<br \/>\nNOTE: The NAMMDR constantly monitors the activity of training providers. In this respect, if you are dissatisfied with the performance of the training providers regarding the manner in which the training is carried out or the quality of the provided services, you can report the negative aspects online at da@anm.ro or dgdm@anm.ro.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-22-06-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>22.06.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that <strong>Commission Implementing Regulation (EU) 2023\/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022\/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017\/745 of the European Parliament and of the Council<\/strong> has been published.<br \/>\nThe Regulation, together with Commission Implementing Regulation (EU) 2022\/2346 of 1 December 2022 laying down common specifications in accordance with Regulation (EU) 2017\/745, for the products listed in Annex XVI, will be applicable from 22 June 2023.<br \/>\n<strong>As a consequence of the full applicability of the Common Specifications, starting from 22 June 2023, the MDR will also become applicable to products without a proposed medical purpose that are listed in Annex XVI to the Regulation.<\/strong><br \/>\nPlease find attached the notification of the European Commission:<br \/>\n<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/RO\/TXT\/HTML\/?uri=CELEX:32023R1194&#038;qid=1687344268439\" rel=\"noopener\" target=\"_blank\">https:\/\/eur-lex.europa.eu\/legal-content\/RO\/TXT\/HTML\/?uri=CELEX:32023R1194&#038;qid=1687344268439<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-19-05-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>19.05.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all stakeholders<\/strong><\/span><br \/>\nPlease be advised that on 12 May 2023, the European Commission published the revision of document MDCG 2020-3 with guidance on the significant changes to the transitional provision in Article 120 of the MDR relating to devices covered by certificates, in line with the MDD or the AIMDD.<br \/>\nThe changes made are as follows:<br \/>\nSection 4.1 \u2013 General provisions:<br \/>\n\u2022 Minor text change to clarify the fact that the changes made in order to comply with other Union legislation fall within the scope of the guidance only if the risk\/benefit balance of the device is not adversely affected.<br \/>\n\u2022 Minor text change and introduction of a footnote regarding the validity of certificates during the transition period.<br \/>\n\u2022 Introduction of a footnote regarding statements listing insignificant changes for Class I devices.<br \/>\nSection 4.2 \u2013 Changes unrelated to design or intended purpose:<br \/>\n\u2022 Introduction of a footnote to rule out changing the legal manufacturer in the first example provided.<br \/>\n\u2022 Introduction of a final statement regarding the notification procedure agreed between the manufacturer and the notified body.<br \/>\nIn section 4.3.2.3 \u2013 Design changes:<br \/>\n\u2022 Improved text in examples related to changes brought to device case and user interface layout, for more clarity.<br \/>\n\u2022 Inclusion of a note on the Benefit\/Risk balance (in bold) in each subsection, for better reading and understanding.<br \/>\nThe European Commission notification can be accessed at: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en <\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/mdcg_2020-3_en.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-11-05-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>11.05.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that on 10 May 2023, the European Commission posted the final draft of the Commission&#8217;s Implementing Regulation, amending the transitional provisions established in Regulation (EU) 2022\/2346 laying down common specifications for the groups of products without an intended medical purpose, on the Commission&#8217;s website and is open for comments until 06.05.2023. Comments can be sent to the Commission.<br \/>\nThis project is proposed for reasons of coherence and in order to provide legal certainty to economic operators by aligning the provisions relating to the transition periods in the Implementing Regulation R(EU) 2022\/2346 for products covered by a certificate issued by a notified body according to Directive 93\/42\/EEC with those of Regulation R(EU) 2017\/745, as amended by Regulation R(EU) 2023\/607.<br \/>\nThe notification of the European Commission is available online at: <a href=\"https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/13830-Amendment-of-common-specifications-for-products-without-intended-medical-purpose-listed-in-Ann-XVI-Reg-EU-2017-745_en\" rel=\"noopener\" target=\"_blank\">Amendment of common specifications for products without intended medical purpose listed in Ann. XVI \u2013 Reg. (EU) 2017\/745 (europa.eu)<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/090166e5fb88e1ca.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-31-03-2023-3\/\">Important notification<\/a><div class=\"content\"><p><strong>31.03.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of economic operators who request the approval of the activity of installation and\/or maintenance of medical gas distribution systems<\/strong><\/span><br \/>\nAs a result of Order no. 2412 of 15.09.2022 on approval of the technical \u201cRegulation on hospital buildings &#8211; NP 015-2022&#8243; issued by the Ministry for Development, Public Works and Administration and of the many requests for clarifications regarding the provisions of this Order, please read the following document.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/Important notification_31.03.2023_EN.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-21-03-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>21.03.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers of medical devices, in vitro diagnostic medical devices, authorised representatives, economic operators and all stakeholders<\/strong><\/span><br \/>\nWe hereby inform you that on 20 March 2023, the European Commission has published Regulation (EU) 2023\/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.<br \/>\nThis Regulation is adopted following exceptional circumstances generated by an imminent risk of shortage of medical devices and the associated risk of a public health crisis.<br \/>\nTransitional provisions for medical devices<br \/>\nThe certificates issued by notified bodies in accordance with the respective directives starting from 25 May 2017, which were still valid on 26 May 2021 and which expired before 20 March 2023, are considered valid until the dates specified in the table below only if one of the following conditions is met:<br \/>\n(a) prior to the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement for assessment of compliance related to the device covered by the expired certificate or related to a device intended to replace that device;<br \/>\n(b) a competent authority of a Member State has granted a derogation from the applicable compliance assessment procedure in accordance with Article 59(1) of Regulation 745\/2017 or has requested the manufacturer, in accordance with Article 97(1) of Regulation 745 \/2017, to carry out the applicable compliance assessment procedure.&#8221;;<br \/>\nMedical devices in the situation described above may be placed on the market or put into operation until the following dates:<\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"302\">Class III devices and Class IIb implantable devices, excluding suture materials, staples, dental filling materials, dental appliances, dental crowns, screws, wedges, metal plate wires, needles, clips and connectors;<\/td>\n<td width=\"227\">Class IIb devices other than those mentioned above and Class IIa and Is\/Im devices;<\/td>\n<td width=\"190\">Devices reclassified in line with the MDR.<\/td>\n<\/tr>\n<tr>\n<td width=\"302\"><strong>31 December 2027<\/strong><\/td>\n<td width=\"227\"><strong>31 December 2028<\/strong><\/td>\n<td width=\"190\"><strong>31 December 2028<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Transitional provisions for in vitro diagnostic medical devices<br \/>\nRegulation (EU) 2017\/746 is amended as follows:<br \/>\n1. Under Article 110, paragraph (4) is replaced by the following text:<br \/>\n\u201e(4) Devices legally placed on the market in line with Directive 98\/79\/EC before 26 May 2022 and devices legally placed on the market after 26 May 2022 pursuant to paragraph (3) of this Article may still be placed on the market or put into service.&#8221;<br \/>\n2. Under Article 112, the second paragraph is replaced by the following text:<br \/>\n\u201cAs regards the devices referred to in Article 110 paragraphs (3) and (4) of this Regulation, Directive 98\/79\/EC shall continue to apply to the extent necessary for the application of the said paragraphs.&#8221;<br \/>\nThe notification of the European Commission is available online here: https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations_en#extension-of-the-transition-periods-provided-for-in-the-regulations<br \/>\nThe European Commission has made available to interested parties a guideline on Questions and Answers on practical issues related to the implementation of Regulation (EU) 2023\/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices which can be downloaded from the European Commission&#8217;s website by accessing the following link:<br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/qa-practical-aspects-related-implementation-regulation-eu-2023607-extension-mdr-transitional-period-2023-03-28_en\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/qa-practical-aspects-related-implementation-regulation-eu-2023607-extension-mdr-transitional-period-2023-03-28_en<\/a><br \/>\n<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32023R0607\" rel=\"noopener\" target=\"_blank\">download regulation &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/LEGISLATIE\/Ghid%20cu%20privire%20la%20%C3%8Entreb%C4%83ri%20%C8%99i%20r%C4%83spunsuri%20privind%20aspectele%20practice%20legate%20de%20punerea%20%C3%AEn%20aplicare%20a%20Regulamentului%20(UE)%202023-607.pdf\" rel=\"noopener\" target=\"_blank\">download guideline &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-14-03-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>14.03.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers of medical devices, in vitro diagnostic medical devices, authorised representatives, economic operators and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that, on 08.03.2023, the European Commission has published the Commission Delegated Regulation (EU) 2023\/502 of 1 December 2022 amending Regulation (EU) 2017\/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies and Commission Delegated Regulation (EU) 2023\/503 of 1 December 2022 amending Regulation (EU) 2017\/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies, changing the deadlines for re-assessment of notified bodies from 3 to 5 years and setting the frequency of their subsequent complete re-assessment every 5 years.<br \/>\nThese Regulations are available here:<br \/>\n<a href=\"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/legislatie\/directive-si-regulamente\/\" target=\"_blank\" rel=\"noopener\">Directives and regulations \u2013 Medical Devices<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-28-02-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>28.02.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all economic operators<\/strong><\/span><br \/>\nPlease note that only manufacturers of medical devices <strong>outside the European Union<\/strong> are required to appoint a single <strong>authorised representative<\/strong> to introduce the device on the EU market.<br \/>\nIn line with Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, &#8220;<strong>authorised representative<\/strong>&#8221; means any physical or legal person established in the EU who has received and accepted a written mandate from a manufacturer outside the Union, to act on behalf of the manufacturer in relation to specified tasks regarding the latter&#8217;s obligations arising from this Regulation.<br \/>\n<strong>Only authorised representatives residing in Romania are required to register into the NAMMDR national database, when introducing the following types of medical devices on the market:<br \/>\na) class I, IIa, IIb and III medical devices, including sterile and\/or measuring devices;<br \/>\nb) systems and procedure sets covered by Article 22 of the Regulation;<br \/>\nc) active implantable medical devices.<br \/>\nAuthorized representatives residing in other member states of the European Union shall NOT BE REGISTERED into the national database.<\/strong><br \/>\nMoreover, free sale certificates are issued for export purposes only to authorised representatives residing in Romania.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-15-02-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>15.02.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that, starting from 13 February 2023, the Methodological rules for clinical evaluation and clinical investigations have entered into force by being published in the Official Gazette of Romania, Part I, No.120 bis\/13.II.2023 of ORDER no. 330 of 13 February 2023 on clinical evaluation and clinical investigations with medical devices and for repeal of Order of the Minister of Health no. 792 of 29 June 2006 on conduct of the procedure for clinical investigation and the procedure for assessment of performance relating to medical devices.<br \/>\nThis Order is available online under section <a href=\"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/legislatie\/ordine-de-ministru\/\" rel=\"noopener\" target=\"_blank\">Legislation\/Medical devices\/Orders of the Minister of health\/2023<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-14-02-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>14.02.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, notified bodies, healthcare institutions and all stakeholders in the field of in vitro diagnostic medical devices<\/strong><\/span><br \/>\nWe hereby inform you that, on 10 February 2023, the European Commission published the 2nd revision of the MDCG 2020-16 Guidance: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017\/746 for in vitro diagnostic medical devices (IVDR).<br \/>\nThe changes brought with the 2nd revision of the guidance refer to minor changes to the examples, the addition of Annex 2 (diagram to help determine the classification of an IVD as CDx).<br \/>\nThis guidance, regarding the application of Regulation (EU) 2017\/746 for in vitro diagnostic medical devices addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarification on the classification rules set out in Annex VIII. This classification guidance also applies to companies providing informational or diagnostic services to EU patients or devices commissioned through distance selling.<br \/>\nThe main purpose of this document is to provide guidance to manufacturers, notified bodies and healthcare institutions on how to classify an IVD before it is placed on the market, on how to make it available on the market or put it into service in the Union.<br \/>\nIt is also intended to inform regulatory authorities and other interested parties when the assessment of the class assigned to an IVD is done by a manufacturer or a healthcare institution.<br \/>\nTherefore, and only upon request of a Member State, or on its own initiative, the Commission, after consulting the Medical Device Coordination Group (MDCG), decides, by means of implementing acts, on the application of Annex VIII to a particular device, or category or group of devices, in order to establish the classification of these devices (Article 47 (3-4) of the IVDR).<br \/>\nThe European Commission announcement is available here: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2020-16-rev2-guidance-classification-rules-vitro-diagnostic-medical-devices-under-2023-02-10_en\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2020-16-rev2-guidance-classification-rules-vitro-diagnostic-medical-devices-under-2023-02-10_en<\/a><br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-02\/md_mdcg_2020_guidance_classification_ivd-md_en.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-13-01-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>13.01.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>For the attention of healthcare professionals and researchers in healthcare institutions who intend to design, manufacture, modify and use in-house devices and all interested parties in the field of medical devices<\/strong><\/span><br \/>\nPlease be informed that, on 10 January 2023, the European Commission published the MDCG 2023-1 guidance: Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017\/745 and Regulation (EU) 2017\/746 intended for in vitro diagnostic medical devices (IVDR).<br \/>\nMedical devices can be manufactured and used within EU healthcare institutions (in-house devices), on a non-industrial scale, to meet the specific needs of target patient groups that cannot be met or cannot be met at the appropriate level of performance, by an equivalent CE marked device available on the market.<br \/>\nMedical devices manufactured and used only within healthcare institutions (in-house devices) are exempt from most of the provisions of Regulation (EU) 2017\/745 on medical devices (MDR) and Regulation (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR), provided that the healthcare institution complies with the conditions set out in Article 5 paragraph (5) of the Regulation.<br \/>\nIn order to ensure the highest level of health protection, Article 5(5) lays down a number of rules concerning the manufacture and use of such in-house medical devices.<br \/>\nThe provisions of Article 5(5) underlie the regulatory control and surveillance of in-house devices. This document provides guidance on the application of some of these rules.<br \/>\nMoreover, this guidance intends to encourage the harmonised application of Article 5(5) by national competent authorities.<br \/>\nBoth Regulations also specify that any physical or legal person offering diagnostic or therapeutic services through distance sales to patients in the European Union must use devices which are compliant with the MDR or IVDR (Article 6 paragraph (2)). Please note that the provision for derogation from Article 5 paragraph (5) applies only to healthcare institutions in the EU.<br \/>\nWhile most of the recommendations in this document relate to both medical devices and in vitro diagnostic medical devices (IVDs), some are specific to IVDs; such cases are explicitly mentioned.<br \/>\nRegulation (EU) 2022\/112 postponed the application of some, but not all, provisions for in-house IVDs. A schematic presentation of the moment of application of provisions of article 5 paragraph (5) of the IVDR can be found in Annex B to this guideline.<br \/>\nPlease note that the corresponding Article 5(5) of the MDR is already fully applicable from 26 May 2021.<br \/>\nThe European Commission announcement is available here: <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-01\/mdcg_2023-1_en.pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/system\/files\/2023-01\/mdcg_2023-1_en.pdf<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/mdcg_2023-1_en.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-23-12-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>23.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that on 9 December 2022, the European Commission published the MDCG 2022-18 Guidance on application of Article 97 of the MDR related to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate.<br \/>\n\u201eLegacy devices\u201d are medical devices, active implantable medical devices and in vitro diagnostic medical devices covered by a valid EC certificate of compliance issued in accordance with Directive 93\/42\/EEC, Directive 90\/385\/EEC or Directive 98\/79\/EC and which continue to be placed on the market after the date of application of Regulation (EU) 2017\/745 (MDR) or Regulation 2017\/746 (IVDR).<br \/>\nIn line with Article 94 of the MDR, if the assessment by the competent authorities of the member states of some medical devices, motivated either by the possibility of posing an unacceptable risk to the health or safety of patients, users or other persons, or which may affect public health or by non-compliance with another requirement of the MDR leads to finding the non-compliance of the medical device with certain requirements of the MDR (in this case, the lack of a valid EC certificate) but not to demonstrating unacceptable risks for the health or safety of patients, users or other persons, or which may affect public health, Article 97 of the MDR may apply.<br \/>\nThe MDCG 2022-18  Guidance aims to achieve a common understanding of and a uniform approach to the application of Article 97 of Regulation (EU) 2017\/745 on medical devices (MDR) in situations where a device is not in conformity with the MDR because its certificate issued under Directive 93\/42\/EEC (MDD) or Directive 90\/385\/EEC (AIMDD) has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR.<br \/>\nThe use of Article 97 MDR in those situations is meant to be a temporary solution. It will contribute to avoiding disruption of supply of devices on the EU market needed for health systems and patients.<br \/>\nIt only applies to devices that are \u2018in transition\u2019 from the MDD or AIMDD to the MDR or, respectively, for which, despite reasonable efforts undertaken by the manufacturer to obtain certification under the MDR, the relevant conformity assessment procedure involving a notified body has not been concluded in time.<br \/>\nIt does not apply to devices for which the certificate issued under the MDD or AIMDD has been suspended or withdrawn by the notified body; in other words, the Directive\u2019s certificate must have been valid at the date of its expiry.<br \/>\nThe announcement of the European Commission is available online at: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-position-paper-application-art97-mdr-legacy-devices-which-mddaimdd-certificate-expires-issuance-2022-12-09_en\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-position-paper-application-art97-mdr-legacy-devices-which-mddaimdd-certificate-expires-issuance-2022-12-09_en<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/mdcg_2022-18_en.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-13-12-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>13.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that Order no. 3539 of 24 November on approval of the Methodological rules for placement on the market of medical devices and registration of economic operators into the European database on medical devices (EUDAMED), as well as into the national database, and on waiver from compliance assessment procedures, was published in the Official Gazette of Romania No. 1180 of 9 December 2022.<br \/>\nThis Order is available online under section <a href=\"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/legislatie\/ordine-de-ministru\/\" rel=\"noopener\" target=\"_blank\">Legislation\/Medical devices\/Orders of the Minister of health<\/a>.<br \/>\nThe request forms can be downloaded from <a href=\"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/formulare-si-tarife\/\" rel=\"noopener\" target=\"_blank\">Forms and tariffs \u2013 Medical Devices<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-12-12-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>12.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers of medical devices, in vitro diagnostic medical devices and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that on 6 December 2022, the European Commission published the MDCG 2022-17 Guidance: MDCG (Medical Device Coordination Group) position paper on \u2018hybrid audits\u2019.<br \/>\nThis paper outlines the Medical Device Coordination Group (MDCG) position on the possible use of hybrid audits by notified bodies under Regulation (EU) 2017\/745 on medical devices (MDR) and Regulation (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR).<br \/>\nThis paper aims to provide a definition for hybrid audits and clarifications with respect to how hybrid audits can be used under MDR and IVDR as advised following the publication of MDCG 2022-143. Certain conformity assessment procedures under the MDR and the IVDR require the notified body to carry out audits of the manufacturer\u2019s quality management system (QMS).<br \/>\nThe assessment procedure must include an audit on the manufacturer\u2019s premises both for the initial assessment and for the periodic surveillance. The same requirement applies, as appropriate, for audits to occur on the premises of the manufacturer\u2019s suppliers and\/or subcontractors. In addition to the terms \u2018premises\u2019 or \u2018on the premises\u2019, also \u2018on-site\u2019 and \u2018off-site\u2019 are used in the MDR and the IVDR to describe where conformity assessment activities take place.<br \/>\nTo clarify the meaning of the term \u2018hybrid audit\u2019, the MDCG agrees on the following definition.<br \/>\nA \u2018hybrid audit\u2019 should be understood as an audit on the premises of the manufacturer or its supplier(s) and\/or subcontractor(s) with at least one auditor present on the premises and other members of the audit team participating from elsewhere using information and communication technologies (ICT).<br \/>\nThe announcement of the European Commission is available online at: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-17-mdcg-position-paper-hybrid-audits-december-2022-2022-12-06_en\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-17-mdcg-position-paper-hybrid-audits-december-2022-2022-12-06_en<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/mdcg_2022-17_en_0.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-06-12-2022-2\/\">Important notification<\/a><div class=\"content\"><p><strong>06.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all stakeholders<\/strong><\/span><br \/>\nWe hereby inform you that on 1 December 2022, Commission Implementing Regulation (EU) 2022\/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017\/745 of the European Parliament and of the Council on medical devices was published in the Official Journal.<br \/>\nRegulation (EU) 2017\/745 lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. Regulation (EU) 2017\/745 further requires the Commission to adopt for groups of products without an intended medical purpose listed in its Annex XVI, common specifications addressing, at least, application of risk management as set out in the general safety and performance requirements laid down in Annex I to that Regulation and, where necessary, clinical evaluation regarding safety.<br \/>\nClassification rules 9 and 10 on active devices in sections 6.1. and 6.2. of Annex VIII to Regulation (EU) 2017\/745 refers to an intended medical purpose, namely for therapy and diagnosis, and therefore cannot be applied to active products without an intended medical purpose, referred to in Article 1 paragraph (2) of this Regulation. Therefore, such products must be classified in class I in accordance with rule 13 of section 6.5. of Annex VIII to Regulation (EU) 2017\/745.<br \/>\nThe announcement of the European Commission is available online at: <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg_impl\/2022\/2346\/oj\" rel=\"noopener\" target=\"_blank\">EUR-Lex \u2013 32022R2346 \u2013 EN \u2013 EUR-Lex (europa.eu)<\/a> \u0219i <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg_impl\/2022\/2347\/oj\" rel=\"noopener\" target=\"_blank\">EUR-Lex \u2013 32022R2347 \u2013 EN \u2013 EUR-Lex (europa.eu)<\/a>.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/CELEX_32022R2346_RO_TXT.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/CELEX_32022R2347_RO_TXT.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-06-12-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>06.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of in vitro diagnostics laboratories in Romania and all stakeholders<\/strong><\/span><br \/>\nPlease be advised that on 30 November 2022, the European Commission published a set of information containing information intended for candidates for the designation of EU reference laboratories.<br \/>\nThis set of information aims to summarize key information in an accessible manner, subject to change. Please consult the relevant legislation and the text of the call for applications for full details and\/or contact the NAMMDR for further information.<br \/>\nThe announcement of the European Commission is available online at: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/updated-information-pack-candidate-eu-reference-laboratories-published-2022-11-30_en\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/updated-information-pack-candidate-eu-reference-laboratories-published-2022-11-30_en<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/md_candidate-laboratories_infopack_en_0.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-23-11-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>23.11.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of economic operators and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that, starting from 22 November 2022, the new tariffs applied for the services provided by the NAMMDR have entered into force by publication in the Official Gazette of Romania, Part I, No.1123\/22.XI.2022 of ORDER No. 3467 of 17 November 2022 on approval of the tariffs for the activities carried out by the National Agency for Medicines and Medical Devices of Romania (NAMMDR) in the field of medical devices.<br \/>\nYou can access this Order under section Medical devices\/ Legislation \u2013 Medical devices\/Orders of the Minister of Health\/2022 &#8211; link:<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/LEGISLATIE\/Ordin%203467-2022.pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/www.anm.ro\/_\/DM\/LEGISLATIE\/Ordin%203467-2022.pdf<\/a><br \/>\nPayment forms can be downloaded from section Forms and tariffs \u2013 Medical devices:<br \/>\n<a href=\"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/formulare-si-tarife\/\" rel=\"noopener\" target=\"_blank\">https:\/\/www.anm.ro\/en\/dispozitive-medicale\/formulare-si-tarife\/<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-07-11-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>07.11.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of authorised representatives, manufacturers, economic operators and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that on 31 October 2022, the European Commission published the MDCG 2022-16 Guidance: Guidance on Authorised Representatives Regulation (EU) 2017\/745 on medical devices (MDR) and Regulation (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR)<br \/>\nThis guidance document is written for authorised representatives, manufacturers and other economic operators, and intends to provide guidance on relevant requirements under the two Regulations.<br \/>\nWhere clarification is already covered by other MDCG guidances, this guidance on authorised representatives includes a reference.<br \/>\nThe requirement to have an authorised representative is not applicable to devices intended for clinical investigation (MDR) or performance study (IVDR).<br \/>\nTo this end, Article 62(2) MDR and Article 58(4) IVDR state that \u2018where the sponsor of a clinical investigation or performance study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative\u2019<br \/>\nAs the legal representative is not defined as the authorised representative, these requirements are not further included in this guidance.<br \/>\nThe announcement of the European Commission is available online at: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-16-guidance-authorised-representatives-regulation-eu-2017745-and-regulation-eu-2017746-2022-10-31_en\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-16-guidance-authorised-representatives-regulation-eu-2017745-and-regulation-eu-2017746-2022-10-31_en<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/mdcg_202216_en.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-31-10-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>31.10.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers of in vitro diagnostic medical devices, economic operators, notified bodies and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that on 04.07.2022, the European Commission published the Regulation (EU) 2022\/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017\/746 of the European Parliament and of the Council.<br \/>\nIn case of some class D in vitro diagnostic medical devices D falling under the scope of Regulation (EU) 2017\/746, there are no harmonised standards as regards some requirements of Annex I to the respective Regulation and it was necessary to address public health concerns, since the risk associated with the use of the respective medical devices is vital for public health and patient safety. Thus, common specifications have been adopted for the concerned devices, as regards the respective requests.<br \/>\nThis Regulation is available online:<br \/>\n<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/RO\/TXT\/PDF\/?uri=CELEX:32022R1107&#038;from=EN\" rel=\"noopener\" target=\"_blank\">https:\/\/eur-lex.europa.eu\/legal-content\/RO\/TXT\/PDF\/?uri=CELEX:32022R1107&#038;from=EN<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-14-10-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>14.10.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of medical devices manufacturers and all stakeholders<\/strong><\/span><br \/>\nOn 13.10.2022, Emergency ordinance regarding the setup of an institutional framework, as well as the necessary measures, in order to ensure direct application of the provisions of Regulation (EU) 2017\/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU, was published in the Official Gazette of Romania, Part I, no. 995<br \/>\nThe ordinance is available online, under section <a href=\"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/legislatie\/legi-ordonante-si-hotarari-de-guvern\/\" rel=\"noopener\" target=\"_blank\">Medical Devices Legislation \u2013 Laws, ordinances and government decisions \u2013 2022<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-10-10-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>10.10.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers of custom-made devices, based in Romania<\/strong><\/span><br \/>\nPlease be informed that Order No. 2845 of 29 September 2022 on approval of the Methodological norms for approval of provisions of Article 13 of Emergency Government Ordinance no. 46\/2021 on the establishment of the institutional framework and the measures necessary to ensure the direct application of the provisions of Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) no. 178\/2002 and Regulation (EC) no. 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC, on registration of custom-made devices placed on the market under their own name by manufacturers based in Romania was published in the Official Gazette of Romania No. 977 of 7 October 2022.<br \/>\nThis Order is available online under section <a href=\"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/legislatie\/ordine-de-ministru\/\" rel=\"noopener\" target=\"_blank\">Legislation\/Medical devices\/Orders of the Minister of health<\/a>.<br \/>\nThe request form can be downloaded from <a href=\"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/formulare-si-tarife\/\" rel=\"noopener\" target=\"_blank\">Forms and tariffs \u2013 Medical Devices<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-19-09-2022-2\/\">Important notification<\/a><div class=\"content\"><p><strong>19.09.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers of in vitro diagnostic medical devices, economic operators, notified bodies and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that on 14 September 2022, the European Commission published the MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD.<br \/>\nThis document provides information related to Article 110 (2) and Article 110 (3) of Regulation (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR) states that medical devices covered by valid certificates issued by a body notified in line with Directive 98\/79\/CE on in vitro diagnostic medical devices \u2013 IVDD can be marketed or commissioned after date of enforcement of the IVDR, no later than 26 May 2025, in some cases.<br \/>\nThe abovementioned conditions require that the notified body which has issued the certificate in line with the IVDD continues to carry out appropriate supervision regarding the applicability of the requirements related to the devices it has certified. It is thus important for manufacturers, notified bodies and national authorities to be clear about the activities taking part in the appropriate surveillance referred to in Article 110(3) of the IVDR.<br \/>\nTo properly address the application of transitional provisions to medical devices covered by certificates issued in line with the IVDD, this guideline, issued in accordance with MDCG 2022-4 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR (<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-4-guidance-appropriate-surveillance-regarding-transitional-provisions-under-article-120-2022-02-16_en\" target=\"_blank\" rel=\"noopener\">https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-4-guidance-appropriate-surveillance-regarding-transitional-provisions-under-article-120-2022-02-16_en<\/a>) and MDCG 2022-8 Regulation (EU) 2017\/746 \u2013 application of IVDR requirements to \u2018legacy devices\u2019 and to devices placed on the market prior to 26 May 2022 (<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-8-regulation-eu-2017746-application-ivdr-requirements-legacy-devices-and-devices-placed-2022-05-20_en\" target=\"_blank\" rel=\"noopener\">https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-8-regulation-eu-2017746-application-ivdr-requirements-legacy-devices-and-devices-placed-2022-05-20_en<\/a>), should be read in conjunction with MDCG 2022-6 \u2013 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR (<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-6-guidance-significant-changes-regarding-transitional-provision-under-article-1103-ivdr-2022-05-04_en\" target=\"_blank\" rel=\"noopener\">https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-6-guidance-significant-changes-regarding-transitional-provision-under-article-1103-ivdr-2022-05-04_en<\/a>).<br \/>\nFor the purpose of this document, \u201elegacy devices\u201d should be understood as devices which, in line with Article 110 (3) of the IVDR, are placed on the market following enforcement of the IVDR (26 May 2022) and until the end of the respective transition period mentioned in Article 110 (3) \u2013 the 2nd or 3rd paragraph, if certain conditions are met.<br \/>\nOnly devices covered by a valid CE certificate, issued in accordance with the IVDD prior to 26 May 2022, are covered in this guide.<br \/>\nThe notification of the European Commission is available online: <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/mdcg_2022-15_en.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/mdcg_2022-15_en.pdf<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-19-09-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>19.09.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers of in vitro diagnostic medical devices, economic operators, notified bodies and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that, on 14 September 2022, the European Commission published the MDCG 2021-22 Rev.1 \u2013 Clarification on \u201cfirst certification for that type of device\u201d and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert group referred to in Article 48(6) of Regulation (EU) 2017\/746.<br \/>\nThis document provides information on Class D devices, Article 48(6) of Regulation (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR) \u2013 sets out the conditions to be applied by the notified body in order to determine whether the expert group must be consulted on the manufacturer&#8217;s performance assessment report.<br \/>\nThese conditions are: (1) the absence of common specifications for the Class D device in question;<br \/>\n(2) where is the first certification for that specific type of device.<br \/>\nThis guideline provides clarification on the meaning of these conditions and the corresponding procedures to be followed by the notified body.<br \/>\nThe notification of the European Commission is available online: <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/mdcg_2021-22_en.pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/mdcg_2021-22_en.pdf<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-14-09-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>14.09.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nTo the attention of economic operators (OE) requesting approval for importing medical devices, in line with Article 2 a) of the Methodological Norms for application of Title XX of Law no. 95\/2006 on healthcare reform, regarding the approval of activities in the field of medical devices (MD), approved through Order of the Minister of Health no. 566\/2020 (Norms).<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/Avizarea activit\u0103\u021bii de import dispozitive medicale.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document&#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-13-09-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>13.09.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all interested persons (users, distributors etc.)<\/strong><\/span><br \/>\nThe National Agency of Medicines and Medical Devices in Romania warns all users of benzocaine-containing local anaesthetic TOPIGEL, manufactured by LABORATORIOS CLARBEN, SA, Spain, wrongly classified as medical devices (class I), to immediately stop using it and return the products to the distributors from whom they purchased them and to report each their own situation to the National Agency for Medicines and Medical Devices of Romania &#8211; Marketing Surveillance Service.<br \/>\nThe National Agency for Medicines and Medical Devices of Romania warns all distributors of benzocaine-based local anaesthetic, TOPIGEL, manufactured by LABORATORIOS CLARBEN, SA, Spain to immediately stop making this product available on the Romanian market, to notify the National Agency of Medicines and Medical Devices of Romania regarding the stock held and the suppliers from whom they obtained these products.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-09-09-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>09.09.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\n<strong>The legal consequences of refusing or delaying an unexpected inspection<\/strong><br \/>\nAs a market surveillance authority, the NAMMDR acts in the interest of economic operators, end users and user specialist staff in order to ensure that the public interests falling under the relevant Union harmonisation legislation for medical devices are permanently maintained and protected by measures ensuring that the appropriate legislation is applied, and that compliance with this legislation is ensured throughout the supply chain through appropriate controls.<br \/>\nIn this capacity, <strong>the NAMMDR has the right to carry out on-site inspections and physical checks of products without prior notification<\/strong>, the right to enter any premises, any area or any means of transportation that the economic operator in question uses for purposes related to its commercial, business or professional activity, to identify non-compliance and obtain evidence (Article 14 paragraph (4) of Regulation (EU) 2019\/1020 on market surveillance and product compliance, amending Directive 2004\/42\/EC and Regulations (EC) No. 765\/2008 and (EU) No. 305\/2011).<br \/>\nArticle 93 of Regulation 2017\/745 on medical devices stipulates that the competent authority carries out both announced inspections and, if required, unannounced inspections at the premises of economic operators as well as at the premises of suppliers and\/or subcontractors and, where necessary, at the units of professional users.<br \/>\nMoreover, it is established through Article 928 of Law 95\/2006, republished, that medical devices commissioned and in use are subject to the following control methods: <strong>unannounced inspection and testing, in-use surveillance<\/strong>.<br \/>\nArticle 8 of Decision no. 306 of 23 March 2011 on measures for the surveillance of the market for products under European Union regulation for harmonised marketing stipulates that surveillance of products placed on the market and\/or commissioned is carried out also by unannounced controls and point checks.<br \/>\nGiven the above, please be informed that <strong>unlawfully obstructing, in any form, the authorised persons to perform their duties mentioned in this title, represents an infringement and is fined from 5,000 to 10,000 lei, in line with Article 935 paragraph 1) point g) of Law 95\/2006 republished<\/strong>.<br \/>\nArticle 18 of Government Ordinance 2\/2001 on the legal regime of contraventions stipulates <strong>that in case of refusal, in order to identify the perpetrator, the official examiner can contact the police, gendarmes or local police<\/strong>. (\u201cArticle 18. The perpetrator is obliged to present to the official examiner, upon request, the identity document or the documents on the basis of which the mentions provided for in Article 16 paragraphs (1) and (11) are made. In case of refusal, in order to identify the perpetrator, the official examiner can contact the police, gendarmes or local policemen.\u201d)<br \/>\nThrough checks carried out and removal of non-compliant medical devices, we aim to ensure a high level of protection of patient and user health and safety, these actions targeting the general public interest.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-08-09-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>08.09.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of legal representatives and persons responsible for medical devices within hospitals<\/strong><\/span><br \/>\nAs a market surveillance authority, the NAMMDR acts in the interest of economic operators, end users and user specialist staff in order to ensure that the public interests falling under the relevant Union harmonization legislation for medical devices are permanently maintained and protected by measures ensuring that the appropriate legislation is applied, and that compliance with this legislation is ensured throughout the supply chain through appropriate controls. In this capacity, the NAMMDR has the right to carry out on-site inspections and physical checks of products without prior notification, the right to enter any premises, any area or any means of transportation that the economic operator in question uses for purposes related to its commercial, business or professional activity, to identify non-compliance and obtain evidence (Article 14 paragraph (4) of Regulation (EU) 2019\/1020 on market surveillance and product compliance, amending Directive 2004\/42\/EC and Regulations (EC) No. 765\/2008 and (EU) No. 305\/2011).<br \/>\nArticle 93 of Regulation 2017\/745 on medical devices stipulates that the competent authority carries out both announced inspections and, if required, unannounced inspections at the premises of economic operators as well as at the premises of suppliers and\/or subcontractors and, where necessary, at the units of professional users.<br \/>\n<strong>Please be informed that during the following period, as part of the market surveillance activity and the control topics established at NAMMDR\/DGDM\/DRSP level, controls will be carried out in hospital units, aiming to assess compliance with the legal provisions in force in the field of medical devices in use.<br \/>\nWithin the respective controls, the following aspects will be checked first and foremost:<\/strong><br \/>\n\u2013 whether a person responsible for maintaining records of medical devices in use and acting as a contact person in the relationship with the NAMMDR is appointed;<br \/>\n\u2013 whether a register of medical devices in use is established according to the methodological norms in force;<br \/>\n\u2013 whether the installation, maintenance and repair of medical devices is ensured with the help of units specialised in performing such services;<br \/>\n\u2013 whether the periodic verification of the used medical devices is ensured, according to legal provisions;<br \/>\n\u2013 whether the medical devices are used only during their shelf life, when applicable, and when they do not present deviations from the functional performances and from the applicable security requirements;<br \/>\n\u2013 whether optimal conditions for keeping and storing medical devices are ensured, according to the requirements specified by the manufacturer;<br \/>\n\u2013 whether the label and instructions for use of the medical devices\/medical device accessories and consumables in use\/storage comply with the requirements set out in Annex I chapter III point 23 of Regulation (EU) 2017\/745, respectively the requirements set out in Annex I chapter III point 20 of Regulation (EU) 2017\/746 in the case of medical devices for in vitro diagnosis.<br \/>\nThe following link: <a href=\"https:\/\/www.anm.ro\/dispozitive-medicale\/supraveghere-in-utilizare\/\">https:\/\/www.anm.ro\/dispozitive-medicale\/supraveghere-in-utilizare\/<\/a><br \/>\nhighlights a part of the legal obligations of professional users of medical devices.<br \/>\nThe legislation considered within the control topics is the following:<br \/>\n\u2013 Law No. 95 Republished*) of 14 April 2006 on healthcare reform &#8211; Title XX<br \/>\n*) It includes all the changes made to the official document published in the Official Gazette, including those provided in: Government Ordinance No. 37\/31.08.2022 Published in the Official Gazette no. 857\/31.08.2022<br \/>\nThis Law is available online:<br \/>\n(<a href=\"https:\/\/www.anm.ro\/_\/DM\/LEGISLATIE\/legea%2095_titlul%20XX_05.09.2022.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/www.anm.ro\/_\/DM\/LEGISLATIE\/legea%2095_titlul%20XX_05.09.2022.pdf<\/a>)<br \/>\n\u2013 ORDER No. 2219 of 14 July 2022 regarding the control through periodic verification of the medical devices in use, the evaluation of the performances of the second-hand medical devices put into operation and the issuance of an approval for use of the medical devices as equipment of healthcare units and of means of intervention for pre-hospital emergency medical assistance;<br \/>\nThe Order is available online:<br \/>\n(<a href=\"https:\/\/www.anm.ro\/_\/DM\/LEGISLATIE\/15.2.%20ORDIN%202219%20DIN%2014%20IULIE%202022.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/www.anm.ro\/_\/DM\/LEGISLATIE\/15.2.%20ORDIN%202219%20DIN%2014%20IULIE%202022.pdf<\/a> )<br \/>\n\u2013 Order of the minister of health no. 2882\/2021 on how to report suspected serious incidents related to medical devices;<br \/>\nThe Order is available online:<br \/>\n(<a href=\"https:\/\/www.anm.ro\/_\/DM\/Ordin%202882-2021.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/www.anm.ro\/_\/DM\/Ordin%202882-2021.pdf <\/a>)<br \/>\n\u2013 Order no. 566\/2020 for approval of the Methodological Norms for application of Title XX of Law no. 95\/2006 on healthcare reform, regarding the approval of activities in the field of medical devices;<br \/>\nThe Order is available online:<br \/>\n(<a href=\"https:\/\/www.anm.ro\/_\/DM\/Ordinul%20nr.%20566%20si%20Anexe.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/www.anm.ro\/_\/DM\/Ordinul%20nr.%20566%20si%20Anexe.pdf<\/a> )<br \/>\n\u2013 REGULATION (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No. 178\/2002 and Regulation (EC) No. 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC. This Regulation is available online:<br \/>\n(<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02017R0745-20200424&amp;qid=1651491231964\" target=\"_blank\" rel=\"noopener\">https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02017R0745-20200424&amp;qid=1651491231964<\/a> )<br \/>\n\u2013 EMERGENCY ORDINANCE no. 46 of 9 June 2021 on establishment of an institutional framework and measures for enforcement of Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No. 178\/2002 and Regulation (EC) No. 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC;<br \/>\nThis Ordinance is available online:<br \/>\n(<a href=\"https:\/\/legislatie.just.ro\/Public\/DetaliiDocument\/243191\" target=\"_blank\" rel=\"noopener\">https:\/\/legislatie.just.ro\/Public\/DetaliiDocument\/243191<\/a>)<br \/>\n\u2013 Regulation (EU) 2017\/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU.<br \/>\nThis Regulation is available online:<br \/>\n(<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02017R0746-20220128&amp;qid=1651491186034\" target=\"_blank\" rel=\"noopener\">https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02017R0746-20220128&amp;qid=1651491186034<\/a>)<br \/>\nThrough the checks carried out and removal of non-compliant medical devices, we aim to ensure a high level of protection of patients\u2019 and users\u2019 health and safety, these actions targeting the general public interest.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-30-08-2022-2\/\">Important notification<\/a><div class=\"content\"><p><strong>30.08.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all persons interested in the issuance of a waiver from assessment of compliance procedures<\/strong><\/span><br \/>\nOn the basis of a justified request, the NAMMDR authorises the placement on the market or commissioning on the territory of Romania of a certain device for which the compliance assessment procedures have not been carried out, but whose use is in the interest of public health or patient health, in line with provisions of Article 59 of Regulation (EU) 2017\/745 on medical devices.<br \/>\nThis national waiver applies for a limited period (the period considered reasonable for completion of the compliance assessment procedure or the necessity in use of the medical devices subject to national waiver), only in exceptional, well-justified cases, when there is no similar product on the market, when the manufacturer demonstrates that he has started the compliance assessment procedures or, as the case may be, that he has been prevented from completing\/initiating these procedures by exceptional and unforeseeable circumstances.<br \/>\nIn order to obtain the waiver, the applicant submits to the NAMMDR an application accompanied by documents justifying the fact that the product is safe to use (declaration of compliance issued by the manufacturer, certificate of compliance issued by a notified body (as applicable), technical specification, label, instructions for use, evidence regarding the lack of complaints\/incidents, evidence regarding the steps taken in view of certification, other certificates\/approvals\/authorisations obtained) as well as evidence regarding the need for the respective medical device on the market (lack of a substitute and the need to cover the respective segment).<br \/>\nTo solve the request, the NAMMDR may additionally request documents provided for in the legislation applicable to the type of medical device.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-30-08-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>30.08.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nGuideline on the ability of notified bodies and the availability of medical devices<br \/>\nPlease be informed that on 26 August 2022, the Medical Devices Coordination Group (MDCG) of the European Commission has issued an opinion document, MDCG 2022-14 \u201dTransition to the MDR and IVDR. Notified body capacity and availability of medical devices and IVDs\u201d, available online: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-14-transition-mdr-and-ivdr-notified-body-capacity-and-availability-medical-devices-and-2022-08-26_en\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-14-transition-mdr-and-ivdr-notified-body-capacity-and-availability-medical-devices-and-2022-08-26_en<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-16-08-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>16.08.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all parties interested in devices without an intended medical purpose<\/strong><\/span><br \/>\nPlease be advised that the final draft of the Implementing Regulation on reclassification of the groups of active products without an intended medical purpose listed in Annex XVI to <strong>Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No. 178\/2002 and Regulation (EC) No. 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC, was posted on the European Commission website, DG SANTE<\/strong>: <a href=\"https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en\" rel=\"noopener\" target=\"_blank\">https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en<\/a><br \/>\nAll those interested may send comments until 8 September 2022.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-25-07-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>25.07.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of in vitro diagnostics laboratories in Romania and all interested parties<\/strong><\/span><br \/>\nThe European Commission Directorate-General for Health and Food Safety (DG SANTE) officially launches a call for applications for the designation of EU reference laboratories in the field of in vitro diagnostic medical devices, in line with Regulation (EU) 2017\/746 on in vitro diagnostic medical devices.<br \/>\nIn accordance with Article 100(1) of Regulation (EU) 2017\/746, applications can only be submitted by Member States through the competent authority.<br \/>\nLaboratories intending to register in order to be designated as an EU Reference Laboratory must strictly comply with several requirements and application deadlines.<br \/>\nMember States are requested to submit registration applications for designation by 31 March 2023, 12:00 CET. The deadline cannot be extended and any application submitted after this deadline will not be considered.<br \/>\nIn order to meet this deadline, it is recommended that candidate laboratories submit their applications to their Member States by 12:00 CET on 5 January 2023.<br \/>\nThe tasks and criteria that must be fulfilled by reference laboratories of the European Union in the field of in vitro diagnostic medical devices for can be found in the Commission Implementing Regulation (EU) 2022\/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017\/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices.<br \/>\nThis Regulation, as well as more information, are available online:<br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/setting-scene-eu-reference-labs-high-risk-diagnostics-2022-06-21_en\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/setting-scene-eu-reference-labs-high-risk-diagnostics-2022-06-21_en<\/a><br \/>\nThose interested are invited to contact the National Agency for Medicines and Medical Devices of Romania in order to obtain all the necessary information in order to register their candidacies at: <a href=\"mailto:dgdm@anm.ro\">dgdm@anm.ro<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-04-07-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>04.07.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of laboratories in the field of in vitro diagnostics in Romania and all interested parties<\/strong><\/span><br \/>\nPlease be advised that two implementing acts related to the application of Regulation (EU) 2017\/746 were published on 22.06.2022 in the Official Journal of the European Union, namely:<br \/>\n<strong>Commission Implementing Regulation (EU) 2022\/944 of 17 June 2022<\/strong> laying down rules for the application of Regulation (EU) 2017\/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices<br \/>\n<strong>Commission Implementing Regulation (EU) 2022\/945 of 17 June 2022<\/strong> laying down rules for the application of Regulation (EU) 2017\/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices<br \/>\nThese refer to the requirements which must be met by laboratories in order to be recognized as EU reference laboratories, their duties and the tariffs which they will charge when carrying out specific activities.<br \/>\nThe evaluation and designation of these laboratories will be done by the European Commission, with the collaboration of the Joint Research Center (JRC), based on the proposals of national authorities.<br \/>\nThe NAMMDR, as the responsible national authority, receives requests from laboratories in Romania which intend to become reference laboratories, in view of a preliminary evaluation.<br \/>\nRequests for information can be sent via e-mail: <a href=\"mailto:dgdm@anm.ro\">dgdm@anm.ro<\/a>. The regulations are posted under the \u201c<a href=\"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/regulamentele-europene-privind-dispozitivele-medicale\/\">Medical devices &#8211; European regulations on medical devices<\/a>\u201d section.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-31-05-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>31.05.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers of medical devices and\/or in vitro diagnostic medical devices in Romania and all interested parties<\/strong><\/span><br \/>\nPlease see the list of harmonised standards for medical devices and in vitro diagnostic medical devices under the <a href=\"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/regulamentele-europene-privind-dispozitivele-medicale\/\" rel=\"noopener\" target=\"_blank\">Medical devices &#8211; European regulations on medical devices<\/a> section.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-11-05-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>11.05.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe NAMMDR would like to inform you about the 9th Romanian Pharmacovigilance Workshop which will be held in Bucharest, between 2-4 November 2022.<br \/>\nThe topics: EudraVigilance news, Signal detection, PASS, PAES, Advanced therapy medicinal products, inspections and audits, SPOR and more\u2026 , presented in English by Dr. Calin A. Lungu.<br \/>\nDetalied information are available in the <a href=\"\/_\/ANUNTURI IMPORTANTE\/AGENDA -Flyer Romania 2022 - FINAL - 17 April 2022.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Agenda<\/a>.<br \/>\n* Due to possible travel or meeting restrictions that might be in place, this workshop may be held online with the same agenda.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-02-03-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>02.03.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers of in vitro diagnostic medical devices in Romania and all interested parties<\/strong><\/span><br \/>\nWe inform you that a public consultation has been launched on the European Commission&#8217;s website regarding the Draft Implementing Regulation and its Annex on common specifications for certain Class D medical devices according to Regulation 2017\/746 on in vitro diagnostic medical devices (IVDR). The deadline for submitting comments is 9 March 2022.<br \/>\nThis document is available online: <a href=\"https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/13304-In-vitro-diagnostic-medical-devices-common-specifications_en\" rel=\"noopener\" target=\"_blank\">In vitro diagnostic medical devices \u2013 common specifications (europa.eu)<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-21-02-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>21.02.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers of in vitro diagnostic medical devices in Romania and all interested parties<\/strong><\/span><br \/>\nREGULATION (EU) 2022\/112 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 amending Regulation (EU) 2017\/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices<br \/>\nPlease be informed that on 28 January 2022, the Official Journal of the European Union published Regulation (EU) 2022\/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017\/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices.<br \/>\nRegulation (EU) 2022\/112, leaving unchanged the IVDR application date of 26 May 2022:<br \/>\n\u2013 provides that devices legally placed on the market through a certificate issued by a notified body in accordance with the current Directive on in vitro diagnostic medical devices (Directive 98\/79\/EC; IVDD) before 26 May 2022 may continue to be placed on the market or commissioned by 26 May 2025.<br \/>\n\u2013 introduces adapted transition periods for devices which are to be subject to a compliance assessment involving bodies notified under the Regulation (IVDR) for the first time, but which have a Declaration of Compliance issued in line with Directive (IVDD) before 26 May 2022. The length of the transition period depends on the risk class of the device in question. Lower risk devices (class B and class A devices in sterile condition) may be placed on the market or commissioned until 26 May 2027, while higher risk devices (class D and class C devices) may only be placed on the market or commissioned until 26 May 2025 and 26 May 2026 respectively. During these extended transition periods, devices must continue to comply with Directive 98\/79\/EC and must not have significant changes in their design and intended purpose.<br \/>\n\u2013 provides an additional period to healthcare institutions manufacturing devices for use in their own premises (i.e. so-called in-house devices) in order to meet the conditions set out in Article 5 of Regulation (EU) 2017\/746 (IVDR).<br \/>\nRegulation (EU) 2022\/112 is available online: <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32022R0112\" rel=\"noopener\" target=\"_blank\">EUR-Lex \u2013 32022R0112 \u2013 EN \u2013 EUR-Lex (europa.eu)<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-23-12-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>23.12.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all users\/distributors of PRP Blood Collection Tubes (Platelet Rich Plasma) \/ manufacturer ANHUI SINIC LABORATORY MEDICINE TECHNOLOGY CO. LTD., China<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices of Romania warns all users and distributors of PRP Collection Tubes (Platelet Rich Plasma) products manufactured by ANHUI SINIC LABORATORY MEDICINE TECHNOLOGY CO. LTD., China <strong>to immediately stop their use or placing them on the market, since their introduction on the EU market was carried out on the basis of falsified compliance documents<\/strong>.<br \/>\nIf you have acquired these products \u2013 <strong>PRP (Sodium Heparin), PRP (Sodium citrate + gel), PRP (Sodium citrate + gel + hyaluronic acid) or any other type of PRP Blood Collection Tubes of this manufacturer, accompanied by the attached documents, do not use them or make them available on the market and notify the Market Surveillance Service of the National Agency for Medicines and Medical Devices of Romania (see the contact details on the NAMMDR website)<\/strong>.<br \/>\nIn order to prevent the introduction of non-compliant medical devices which do not comply with the applicable regulatory requirements into the legal distribution chain, particularly in the context of the COVID-19 pandemic, please exercise maximum caution, constantly consult the website of the National Agency for Medicines and Medical Devices of Romania for such information and make sure that the products you purchase come from distributors approved by our institution, in accordance with the provisions of Article 926 of Law 95\/2006 on healthcare reform, republished, with further amendments and supplementations.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/DoC%20+%20EC%20Certificate.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">descarca documentul&#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-14-12-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>14.12.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of Romanian hospitals and all interested parties<\/strong><\/span><br \/>\n<strong>Invitation for hospitals to explore traceability solutions for non-sterile surgical sets<\/strong> \u2013 Solutions to capture full Unique Device Identifier (UDI-DI and UDI-PI)<br \/>\nThe new EU regulations of MDR 2017\/745 introduce a medical device identification system based on a unique device identifier (UDI), which allows easier traceability. These regulations require healthcare facilities to store and preserve, preferably in electronic format, UDIs of devices they have provided or which have been provided to them, if those devices are class III implantable devices. For implantable devices other than Class III, Member States shall encourage and may require healthcare institutions to store and retain, preferably in electronic format, the UDIs of the devices provided to them.<br \/>\nIn order to find the best solutions for implementing these requirements within hospitals, following the request of the European Commission, it was decided to form a group of stakeholders from hospitals and medical device manufacturers, which will be led by MedTech Europe.<br \/>\nPlease find attached the invitation to participate in this group.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/061221_Invitation%20for%20Hospitals_Focus%20group%20on%20traceability%20solutions%20for%20non-sterile%20surgical%20sets.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">descarca documentul&#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-06-12-2020\/\">Important notification<\/a><div class=\"content\"><p><strong>06.12.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\n<strong>Submission and receipt of messages by e-mail (e-mail@anm.ro) <\/strong><br \/>\nIn line with the NAMMDR IT&amp;C security procedures and the European Commission&#8217;s recommendations to counter phishing attacks, message authentication, reporting and compliance will only be domain-based (Domain-based Message Authentication, Reporting and Conformance &#8211; DMARC).<br \/>\nSecurity issues required for e-mail delivery to the anm.ro domain:<br \/>\n<strong><span style=\"color: green;\">\u2713<\/span><\/strong> DMARC (Domain-based Message Authentication, Reporting and Conformance)<strong><br \/>\n<strong><span style=\"color: green;\">\u2713<\/span><\/strong><\/strong> SPF (Sender Policy Framework)<strong><strong><br \/>\n<strong><span style=\"color: green;\">\u2713<\/span><\/strong><\/strong><\/strong> Reverse DNS<strong><strong><strong><br \/>\n<strong><span style=\"color: green;\">\u2713<\/span><\/strong><\/strong><\/strong><\/strong> No Open Relay<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-15-11-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>15.11.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of Romanian manufacturers of medical devices<\/strong><\/span><br \/>\n<strong>UDI\/Device registration \u2013 in EUDAMED<\/strong><br \/>\nThe new EU regulations of <strong>MDR 2017\/745 and IVDR 2017\/746<\/strong> introduce a medical device identification system based on a unique device identifier (UDI), which allows easier traceability. These regulations require medical device manufacturers to submit UDI\/Device information for all medical devices they place on the market. The UDI-DI\/Device module of EUDAMED is used for this purpose.<br \/>\nFrom October 2021, EUDAMED&#8217;s UDI-DI\/Device module is available and manufacturers can already enter the UDI\/Device information into the system voluntarily.<br \/>\nFor more information, we recommend that you access the European Commission website: <a href=\"https:\/\/ec.europa.eu\/health\/md_eudamed\/udi_devices_registration_ro\" rel=\"noopener\" target=\"_blank\">https:\/\/ec.europa.eu\/health\/md_eudamed\/udi_devices_registration_ro<\/a><br \/>\nThe guideline providing all the information required in order to register UDI\/Devices into the Eudamed can be accessed here: <a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_eudamed\/docs\/md_eudamed_udi-devices-user-guide_en .pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_eudamed\/docs\/md_eudamed_udi-devices-user-guide_en.pdf<\/a> <\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-20-07-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>20.07.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of Romanian manufacturers of medical devices\/authorised representatives<\/strong><\/span><br \/>\n<strong>Registration of &#8220;Legacy devices&#8221; into the EUDAMED<\/strong><br \/>\n&#8220;Legacy devices&#8221; are defined as medical devices, active implantable medical devices and in vitro diagnostic medical devices <strong>covered by a valid EC certificate of compliance issued in accordance with Directive 93\/42\/EEC, Directive 90\/385\/EEC or Directive 98\/79\/EC and which continue to be placed on the market after the date of application of Regulation (EU) 2017\/745 (MDR) or Regulation 2017\/746 (IVDR)<\/strong>.<br \/>\n&#8220;Legacy devices&#8221; are subject to MDR or IVDR registration requirements, with some exceptions, such as the assignment of a base UDI-DI and a UDI-DI.<br \/>\nManufacturers will have the possibility to register any of the &#8220;legacy devices&#8221; in EUDAMED. Indications regarding the registration of &#8220;Legacy devices&#8221; in EUDAMED are provided in the document &#8220;MDCG 2019-5 Registration of legacy devices in EUDAMED April 2019&#8221; (<a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/34922\" rel=\"noopener\" target=\"_blank\">https:\/\/ec.europa.eu\/docsroom\/documents\/34922<\/a>).<br \/>\nAlthough the assignment of a basic UDI-DI and UDI-DI is not necessary for a &#8220;legacy device&#8221;, in order to keep the same standard structure and identifiers for all devices registered into the EUDAMED, an EUDAMED DI identifier (the equivalent of the UDI- Basic DI) will be required and a EUDAMED ID (if no UDI-DI has been assigned) will be generated from the EUDAMED DI.<br \/>\nThe basic UDI-DI will never be applicable and assigned to a &#8220;legacy device&#8221;, only the EUDAMED DI will.<br \/>\nThe UDI-DI can be used to identify a legacy device into the EUDAMED, however, only one device identifier will be assigned to a &#8220;legacy device&#8221;, as follows:<br \/>\n\u2022 either a UDI-DI (where EUDAMED DI is automatically generated),<br \/>\n\u2022 either a EUDAMED DI (where the EUDAMED ID is automatically generated).<br \/>\nFor more information, please read the document &#8220;Management of Legacy Devices &#8211; MDR EUDAMED&#8221;: <a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_eudamed\/docs\/legacy_dvc_management_en.pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_eudamed\/docs\/legacy_dvc_management_en.pdf<\/a> <\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-07-06-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>07.06.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of Romanian manufacturers of medical devices\/authorised representatives<\/strong><\/span><br \/>\n<strong>European Medical Device Nomenclature (EMDN)<\/strong><br \/>\nWe inform you that starting from 04.05.2021, the European Medical Device Nomenclature (EMDN), as defined by Article 26 of the Medical Device Regulation (EU) 2017\/745 (MDR) and Article 23 of the Medical Device Regulation (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR), its platform and the English translation validation consultation are officially posted online: <a href=\"https:\/\/webgate.ec.europa.eu\/dyna2\/emdn\/\" rel=\"noopener\" target=\"_blank\">https:\/\/webgate.ec.europa.eu\/dyna2\/emdn\/<\/a>.<br \/>\nThe Italian version of the nomenclature is deemed final and official. The English version is subject to validation through this online consultation for one month.<br \/>\nThe EMDN is used by manufacturers to register medical devices into the EUDAMED, where each device will be associated with each unique device identifier \u2013 device identifier (UDI-DI). The EMDN is intended to support all actors in their activities under MDR \/ IVDR and provides key descriptions of medical devices.<br \/>\nEMDN is characterised by its alphanumeric structure which is established in a multi-level hierarchical tree. It groups medical devices into three main tiers. The first hierarchical level is the &#8220;Category&#8221; level, the second is the &#8220;Group&#8221; level, and the third is the &#8220;Type&#8221; level.<br \/>\nEach medical device is classified by an alphanumeric code containing a letter referring to &#8220;Category&#8221;, 2 numbers referring to &#8220;Group&#8221; and between 1 and 5 two-digit numbers referring to &#8220;Type&#8221;, up to a maximum of 7 levels of detail.<br \/>\nThere are 22 categories for the first hierarchical level &#8220;Category&#8221;. Each is identified by a letter of the alphabet. Each category includes devices regulated in the MDR or IVDR. The categories are divided into 8 anatomical categories.<br \/>\nThe second hierarchical level &#8220;Group&#8221; contains 146 groups of anatomical \/ functional medical devices. These are the differentiations to distinguish between devices in these categories and are identified by two-digit numbers from 01 to 99 for each category. Number 90 identifies groups of devices which possess various characteristics not related to the existing groups, while number 99 (&#8220;other&#8221;) is reserved for medical devices which are not included in the already existing groups and which shall be classified in future updates.<br \/>\n&#8220;Type&#8221; represents the third hierarchical level. It can be expanded to 7 levels of detail, each defined in the code by a two-digit number. Each type level includes medical devices characterised by a high affinity for use, intended use, or a similar clinical method.<br \/>\nAs regards accessories, each accessory will inherit the EMDN classification code of the medical device with which it is associated. If the accessory can be used with several devices belonging to different groups, it will be assigned the predominant type code.<br \/>\nAlthough the EUDAMED is not yet fully operational, implementation of the first module on actor registration started in December 2020, while the second module for UDI registration was announced for September 2021. Manufacturers are therefore advised to already start preparing for these EUDAMED registration requirements in order to be ready to submit the requested information as soon as the various database modules become operational.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-18-05-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>18.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of stakeholders<\/strong><\/span><br \/>\nThe unique identification system of medical devices (UDI), in accordance with Regulations (EU) 2017\/745 and 2017\/746 on medical devices.<br \/>\n<a href=\"\/_\/DM\/Sistemul unic de identificare a dispozitivelor UDI.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">descarca documentul&#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-12-01-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>12.01.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of Romanian manufacturers of medical devices\/authorised representatives\/importers<\/strong><\/span><br \/>\nUsing the EUDAMED &#8220;actors&#8221; registration module and the single registration number (SRN)<br \/>\nThe setup of a European database on medical devices (EUDAMED) is one of the key aspects of the new regulations on medical devices (Regulation (EU) 2017\/745) and in vitro diagnostic medical devices (Regulation (EU) 2017\/746).<br \/>\nThe EUDAMED will provide a real picture of the lifecycle of medical devices made available in the European Union (EU). It will integrate various electronic systems to collect and process information about medical devices and related companies (e.g. manufacturers). In this respect, the EUDAMED aims to increase overall transparency, including through better access to information for the public and healthcare professionals, and to strengthen coordination between the various EU Member States.<br \/>\nEUDAMED contains 6 modules, as follows:<br \/>\n1. Registration of the actors<br \/>\n2.unique device identification (UDI) and registration of medical devices,<br \/>\n3. notified bodies and issued certificates,<br \/>\n4. clinical investigations and performance studies,<br \/>\n5. vigilance<br \/>\n6. Market surveillance.<br \/>\nThe actor registration module is active as of 1 December 2020. In accordance with Article 30 (1) of the MDR, the actor registration module must allow the creation of a single registration number (&#8220;SRN&#8221;) and the collection and processing of information necessary to identify the manufacturer (including producers of system\/procedure packs) and , if applicable, of the authorised representative and importer. As such, the actor registration module is a prerequisite for the use of the other EUDAMED modules and facilitates a secure way of accessing the EUDAMED.<br \/>\nActors involved in the EUDAMED are:<br \/>\n\u2022 Supervisory bodies<br \/>\n\u2013 The European Commission<br \/>\n\u2013 Competent Authorities (CAs), including designation authorities<br \/>\n\u2013 Notified Bodies (NB)<br \/>\n\u2022 Economic operators<br \/>\n\u2013 Manufacturers<br \/>\n\u2013 Manufacturers of systems and procedures packages<br \/>\n\u2013 Authorised representatives<br \/>\n\u2013 Importers<br \/>\n\u2022 Sponsors (clinical investigation financers)<br \/>\nFollowing the evaluation and approval of the request by the competent national authority in question (the NAMMDR), the EUDAMED generates the SRN of the economic operator to the competent national authority and transfers it to the requesting economic operator.<br \/>\nMore information here: https:\/\/ec.europa.eu\/health\/md_eudamed\/actors_registration_ro.<br \/>\nYou can access the guide containing all the information needed to register actors in the Eudamed at:<br \/>\n<a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/md_eudamed\/docs\/md_user_guide_actor_module_en.pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/ec.europa.eu\/health\/sites\/health\/files\/md_eudamed\/docs\/md_user_guide_actor_module_en.pdf<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-04-09-2020\/\">Important notification<\/a><div class=\"content\"><p><strong>04.09.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of Romanian manufacturers\/authorised representatives\/importers<\/strong><\/span><br \/>\nThe use of the EUDAMED &#8220;actors&#8221; registration module and of the single registration number (SRN) in member states<br \/>\nArticle 33 of Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereinafter referred to as the \u201eMDR\u201d) establishes that, following consultation with the Medical Devices Coordination Group (MDCG), the Commission will create, maintain and manage the European database on medical devices (EUDAMED). EUDAMED contains several electronic systems (so-called &#8220;modules&#8221;), including an electronic system for registering economic operators, called the Actor registration module.<br \/>\nIn line with Article 30 (1) of the MDR, the actor registration module should allow the setup of a single registration number (\u201eSRN\u201d), gathering and processing the information required in order to identify the manufacturer (as well as the producers of system\/procedure packs) and, if appropriate, the authorised representative and importer. Therefore, the actor registration module is a prerequisite for using the other EUDAMED modules and facilitates a secure way of accessing EUDAMED.<br \/>\nThe responsibility for assigning a SRN to economic operators belongs to the NAMMDR, as the competent authority. For this purpose, Article 31 paragraph (2) stipulates that, after the verification and validation of the data entered into the EUDAMED by an economic operator, the competent authority of a member state must obtain a SRN from the actor registration module and approve its release to the manufacturer, the authorised representative or the importer who requested this.<br \/>\nOn 30 October 2019, the Commission published an information by which it reached the conclusion that the full functionality of the EUDAMED requires the availability and full operation of all six modules and confirmation through an audit. The information foresees the launch of a fully functional EUDAMED for May 2022.<br \/>\nHowever, in its meeting of 12 March 2020, the MDCG agreed that each EUDAMED module can be made available, gradually, as soon as it is operational. The commission has confirmed the availability to launch the actor registration module starting with 1 December 2020. MDCG members strongly encourage the use of the actor registration module by all relevant actors in their territories, including the use of the SRN by actors, as stipulated in the MDR (e.g. specifying the SRN on certificates).<br \/>\nMDCG members agree that double registration requirements for actors should be avoided as much as possible. Therefore, consideration should be given to actors obtaining an SRN in accordance with actor registration requirements (for manufacturers, authorised representatives, importers, producers of system\/procedure packs) to the extent that national legislation allows this. In such cases, actors should comply with MDR obligations and requirements related to both the registration of the relevant actors (via the &#8220;actors&#8221; registration module) and the use of their SRN, as required.<br \/>\nThe NAMMDR announced its intention to participate in the voluntary registration into the EUDAMED, as soon as the actor registration module is functional.<br \/>\nTaken from: <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2020-08\/2020-15-position-paper-actor-registration-module_en_0.pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/system\/files\/2020-08\/2020-15-position-paper-actor-registration-module_en_0.pdf<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-16-06-2020\/\">Important notification<\/a><div class=\"content\"><p><strong>16.06.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe NAMMD would like to inform you about the 7th Romanian Pharmacovigilance Workshop which will be held in Bucharest, between 21- 23 September 2020 <strong>\u201eEudraVigilance news, Signal detection, Covid-19 pharmacovigilance, MedDRA 23.1, inspections and audits, risk management plans and more\u2026\u201d<\/strong> presented in English by Dr. Calin A. Lungu, CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg. Detalied information are available at <a href=\"https:\/\/www.anm.ro\/_\/ANUNTURI IMPORTANTE\/Agenda_Flyer Romania 2020 - FINAL - 08 June 2020.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><strong>Agenda<\/strong><\/a>.<br \/>\nThe event will take place at Crown Plaza Hotel, Bvd. Poligrafiei 1, sector 1, Bucharest.<br \/>\nFor registration, please download the registration form (<a href=\"https:\/\/www.anm.ro\/_\/ANUNTURI IMPORTANTE\/Reg form_Farmacovigilenta_21-23Sep2020.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><strong>Registration Form<\/strong><\/a>) or contact the event organizer in Romania at the following contact data:<br \/>\nMr. Alexandru Popescu, Business Travel Turism S.R.L.<br \/>\nFax: +4021 3126708, Tel: +4021 2315615<br \/>\nEmail: <a href=\"mailto:alexandru.popescu@businesstravel.ro\"><strong>alexandru.popescu@businesstravel.ro<\/strong><\/a><br \/>\n<em>*Due to possible travel or meeting restrictions that might be in place, this workshop may be held online with the same agenda.<\/em><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-12-03-2020\/\">Important notification<\/a><div class=\"content\"><p><strong>12.03.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nConsidering the current epidemiological context, in order to best possibly avoid trips for document exchange, the NAMMDR has decided on restriction, from 13 March to April 15 2020 (with possible extension should the situation so require), of the activity of the Registry service involving contact with the public. Therefore, documents may be submitted as follows:<br \/>\n<strong>Medicines for human use<\/strong><br \/>\n&#8211; by regular mail, to Str. Av. S\u0103n\u0103tescu nr. 48, sector 1, 011478 Bucharest, Romania<br \/>\n&#8211; by fax, to: + 4021-316.34.97<br \/>\n&#8211; by electronic mail, to:<br \/>\n     &#8211; <a href=\"mailto:registratura@anm.ro\">registratura@anm.ro<\/a><br \/>\n     &#8211; CESP,<br \/>\n     &#8211; the single electronic contact point (PCU-e).<br \/>\n<strong>Medical devices<\/strong><br \/>\n&#8211; by regular mail, to: Bd. Nicolae Titulescu 58, Sector 1, 011144, Bucharest, Romania<br \/>\n&#8211; by fax, to: + 4021-222.86.83<br \/>\n&#8211; by electronic mail, to:<br \/>\n     &#8211; <a href=\"mailto:dgdm@anm.ro\">dgdm@anm.ro<\/a>,<br \/>\n     &#8211; the single electronic contact point (PCU-e).<br \/>\nTo receive documents issued by the NAMMDR during the same period, we recommended using courier services.<br \/>\nAt the same time, all parties interested are advised that meetings requested shall be suspended during the specified period.<br \/>\nThank you for your understanding and cooperation.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/anunt-important-08-11-2011-2\/\">Important notification<\/a><div class=\"content\"><p><strong>08.11.2011<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>Customer satisfaction evaluation questionnaire<\/strong><\/span><br \/>\nContributing to permanent improvement of Technical Laboratories Department work, we hereby kindly invite our customers to fill in the attached questionnaire, to be returned to fax nr. +40 212228683:<br \/>\n<a href=\"\/en\/_\/DM\/Medical%20devices_Important%20notifications_Chestionar%20de%20eval.doc\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/anunt-important-08-11-2011\/\">Important notification<\/a><div class=\"content\"><p><b>08.11.2011<\/b><br \/>\n<span style=\"color: #333399;\"><b>News on medical devices<\/b><\/span><br \/>\nIn result of the monitoring of technical-medical units work, certified by the Minister of Health or under approval, that also have certified and implemented Quality Management System SR EN ISO 9001:2008 or SR EN ISO 13485:2004 with certifying bodies accredited by a national accreditation body (the RENAR- Romanian Accreditation Association or similar), as well as of consultations and dialogue conducted with part of these certifying bodies, the NAMMD Department for Evaluation of technical-medical units specifies a follows:<br \/>\n-The field of medical devices is regulated by European directives (93\/42, 98\/79, 90\/365) and, based on Article 6 of Law No.176\/2000 on medical devices, as republished and amended, as well as of Order of the Minister of Health No.1636\/2007, as amended, the NAMMD performs evaluation of organizations providing services in the field of medical devices (medical optics, orthopaedic\/hearing\/other type prosthetics or repair, verification and setting into operation of medical devices);<br \/>\n-The NAMMD \u201csets up specific technical procedures in medical devices\u201d, \u201con Ministry of Health request, it evaluates and\/or audits legal and natural entities applying for approval of operation\u201d (Article 7 of the law mentioned above) and prepares the assessment report based on which the Ministry of Health grants such approval (Article 2 (2) of Order of the Minister of Health No.1636\/2007);<br \/>\n-The assessment report prepared by the NAMMD confirms that the natural or legal person seeking approval of operation meets all the working conditions, technical-material endowment, qualification, capability, procedures and instructions to perform that activity.<br \/>\nLong term monitoring of the quality of services rendered by medical devices service providers has shown the NAMMD that not all can prove capacity to provide services consistently meeting both customers\u2019 expectations and regulatory requirements applicable to this field. In that respect, certification of the quality management system has proved imperative, as proof of meeting such requirements.<br \/>\nGiven that activities assessed are conducted in the field of medical devices and have serious implications on public health, based on legislation in the field and taking into account the limited number of accredited bodies in Romania for certification of the quality management system according to SR EN ISO 13485 (specific to medical devices), and that most bodies accredited for SR EN ISO 9001:2008 certification do not employ technical experts and auditors qualified and experienced in medical devices, in order to ensure compliance of work by medical devices service with requests of such standards, the NAMMD has prepared its own assessment technical procedure.<br \/>\nThe institution has not sought control of such activities, but only to ensure their conduct by suitably qualified personnel.<br \/>\nWhereas CAEN Codes 3313, 3314 and 332 codes do not make explicit reference to repair, verification and start-up of medical devices, and NAMMD experience has not found that auditors\/experts of audit teams are at all times acquainted with laws specific to the field, a procedure for approval of certifying bodies has been found necessary; therefore, the response of certifying bodies has been difficult to understand, inasmuch that the NAMMD only target had been a more thorough analysis of compliance with specific requirements in the field.<br \/>\nAs an approach that has been misunderstood, the procedure for approval of certifying bodies for assessment of technical-medical units has been discontinued; in that respect, only the requirement concerning the quality management system certification by an accredited certifying body has been maintained.<br \/>\nAs before, evaluation of technical-medical units applying for grant of approval for operation, as well as surveillance assessment of these units are currently conducted by the NAMMD-EUTM Department, based on a procedure of its own.<\/p>\n<\/div><\/li><\/ul><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":469,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1092","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/1092","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=1092"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/1092\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/469"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=1092"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}