{"id":4800,"date":"2017-04-11T12:07:20","date_gmt":"2017-04-11T12:07:20","guid":{"rendered":"http:\/\/wwwro.anm.ro\/?page_id=4800"},"modified":"2026-05-04T15:47:53","modified_gmt":"2026-05-04T12:47:53","slug":"investigatie-clinica","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/investigatie-clinica\/","title":{"rendered":"Clinical investigation"},"content":{"rendered":"

Clinical investigations with medical devices and evaluation of the performance with in vitro diagnostic medical devices<\/strong><\/p>\n

A \u2018clinical investigation<\/strong>\u2019 is defined as any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device of a medical device;<\/p>\n

A \u2018performance study<\/strong>\u2019 is a study undertaken to establish or confirm the analytical or clinical performance of a device;<\/p>\n

\u2018Performance evaluation<\/strong>\u2019 covers the assessment and analysis of data to establish and verify the scientific validity, analytical performance and, where applicable, clinical performance of an in vitro diagnostic medical device.<\/p>\n

An \u2018Investigational Device<\/strong>\u2019 is a device being evaluated in the context of a clinical investigation.<\/p>\n

A ‘(in vitro diagnostic) device for performance study<\/strong>‘ means a device intended by the manufacturer to be used in a performance study.<\/p>\n

A device intended<\/strong> to be used<\/strong> for research purposes, without any medical objective<\/strong>, shall not be deemed to be a device for performance study.<\/p>\n

\u2018Performance of a device<\/strong>\u2019 (in vitro diagnostic medical device) means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose;<\/p>\n

\u2018Analytical performance<\/strong>\u2019 means the ability of a device to correctly detect or measure a particular analyte. <\/p>\n

\u2018Clinical Performance<\/strong>\u2019 means the ability of a device to yield results that are correlated with a particular clinical condition, a physiological or pathological process, or in accordance with the target population and intended user;<\/p>\n

Clinical investigation endpoints:<\/p>\n

(a) establishing and verifying whether the performance of the devices is as established by the manufacturer.<\/p>\n

(b) establishing and verifying a device\u2019s clinical benefits as specified by its manufacturer;<\/p>\n

(c) determining any undesirable adverse reaction under normal circumstances of use and whether these are considered risks in relation to the device\u2019s intended performance.<\/p>\n

In order to approve the conduct of a clinical investigation, the sponsor\/authorised representative submits an application to the NAMMDR; the form is available online<\/strong>: https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_sector\/docs\/mdcg_2021-8_annex1.pdf<\/a>. Depending on the risk class of the device, the existence of the CE mark and the purpose of the clinical investigation, this can be adapted.<\/p>\n

The application is registered only if accompanied by proof of payment of the fee in line with Order of the Minister of Health no. 3467 of November 17, 2022, Annex 1, point 3 \u2013 Clinical investigation<\/p>\n

((https:\/\/www.anm.ro\/_\/DM\/Anexa%201%20tarife%20ANMDMR-DM.pdf<\/a>))<\/p>\n

The form for payment of the fee can be downloaded from the Forms and fees page:<\/p>\n

https:\/\/www.anm.ro\/dispozitive-medicale\/formulare-si-tarife\/<\/a><\/p>\n

Following completion of the form for payment of the fee, this shall be submitted to the NAMMDR headquarters of 48 Aviator Maior \u0218tefan S\u0103n\u0103tescu, Sector 1, 011478, Bucharest, and the respective request shall be invoiced by the NAMMDR. After making the payment and confirming it, you can register your application at the NAMMDR headquarters of 48 Aviator Maior \u0218tefan S\u0103n\u0103tescu, Sector 1, 011478, Bucharest.<\/p>\n

Upon registration of applications for the conduct of clinical investigations, performance studies and substantial modifications to them, the files must be complete, in accordance with the legislation in force and must include the ethical opinion issued by the National Bioethics Committee for Medicinal Products and Medical Devices (CNBMDM)<\/strong>, in order to meet the evaluation deadline and avoid rejection of the applications.<\/p>\n

The NAMMDR approves applications for conduct of clinical investigations and clinical performance studies only if accompanied by an ethical opinion issued by the National Bioethics Committee for Medicinal Products and Medical Devices (CNBMDM) and by the documents provided for in Annex XV of the MDR and Annex XIV of the IVDR, as required. The CNBMDM can be contacted at: http:\/\/www.bioetica-medicala.ro<\/a>; https:\/\/www.adsm.ro\/comisia-de-bioetica-a-medicamentului-si-a-dispozitivelor-medicale\/<\/a>; e-mail: comisia.bioetica@gmail.com<\/a>.<\/p>\n

The structure and the Regulation for organisation and operation of the National Bioethics Committee for Medicinal Products and Medical Devices (CNBMDM) are approved through Order of the Minister of Health no. 80\/2023<\/a>.<\/p>\n

Clinical investigations with medical devices and clinical performance assessment studies with in vitro diagnostic medical devices are conducted in compliance with the principles of good clinical practice, in accordance with the SR EN ISO 14 155 and ISO 20 916 standards<\/strong>. <\/p>\n

The NAMMDR assesses and validates the requests for changes and assesses and authorizes the files for clinical investigations with medical devices, as well as their substantial changes, according to:<\/p>\n

\u2022 MDR, Articles 61- 82, Annexes XIV and XV of 26 May 2021;<\/p>\n

\u2022 IVDR, Articles 56 \u201377, Annexes XIII and XIV of 26 May 2022;<\/p>\n

\u2022 Emergency Government Ordinance no. 46\/09.06.2021 on national rules on clinical assessment and clinical investigations with medical devices, Article 16.<\/p>\n

\u2022 Government Emergency Ordinance no. 137\/12.10.2022;<\/p>\n

\u2022 Order of the Minister of health no. 330\/13.02.2023.<\/strong><\/p>\n

Useful documents:<\/strong><\/p>\n

Guidelines approved by the Medical Devices Coordination Group (MDCG) of the European Commission, DG SANTE, available online at: https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en<\/a>:<\/p>\n

\u2022\t2023\/C 163\/06 \u2013 Commission Guidance on the content and structure of the summary of the clinical investigation report, available online at: https:\/\/eur-lex.europa.eu\/legal-content\/RO\/TXT\/PDF\/?uri=CELEX:52023XC0508(01)<\/a><\/p>\n

\u2022\tGuidance MEDDEVs \u2013 2.7\/1 rev.4 , available online at https:\/\/health.ec.europa.eu\/system\/files\/2022-01\/md_guidance_meddevs_0.pdf<\/a>, available on the Directives webpage: https:\/\/health.ec.europa.eu\/medical-devices-sector\/directives_en<\/a><\/p>\n

\u2022\tMDCG 2021-6 \u201dRegulation (EU) 2017\/745 \u2013 Questions & Answers regarding clinical investigation\u201d, https:\/\/health.ec.europa.eu\/system\/files\/2021-04\/mdcg_2021-6_en_0.pdf<\/a>.<\/p>\n

\u2022\tMDCG 2021-08 \u2013 \u201dClinical investigation application\/notification documents\u201d, https:\/\/health.ec.europa.eu\/system\/files\/2021-05\/mdcg_2021-8_en_0.pdf<\/a>.<\/p>\n

\u2022\tMDCG 2021-28 \u201dSubstantial modification of clinical investigation under Medical Device Regulation\u201d, https:\/\/health.ec.europa.eu\/system\/files\/2022-01\/mdcg_2021-28_en.pdf<\/a>.<\/p>\n

\u2022\tMDCG 2020-10\/1 \u201dSafety reporting in clinical investigations of medical devices under the Regulation (EU) 2017\/745\u201d, https:\/\/health.ec.europa.eu<\/a>.<\/p>\n

\u2022\t\u201dMDCG 2020-10\/2 \u2013 Form for SAE reporting\u201d;<\/p>\n

\u2022\tMDCG 2020-7 \u201dPost-market clinical follow-up (pmcf) plan template a guide for manufacturers and notified bodies\u201d, https:\/\/health.ec.europa.eu\/system\/files\/2020-09\/md_mdcg_2020_7_guidance_pmcf_plan_template_en_0.pdf<\/a>.<\/p>\n

\u2022\tMDCG 2020-8 \u201dPost-market clinical follow-up (PMCF) Evaluation Report Template A guide for manufacturers and notified bodies\u201d, https:\/\/health.ec.europa.eu\/system\/files\/2020-09\/md_mdcg_2020_8_guidance_pmcf_evaluation_report_en_0.pdf<\/a>.<\/p>\n

\u2022\tMDCG 2022-10 \u201dQ&A on the interface between Regulation (EU) 536\/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR)\u201d, https:\/\/health.ec.europa.eu\/system\/files\/2022-05\/mdcg_2022-10_en.pdf<\/a>.<\/p>\n

\u2022\tMDCG 2020-1 \u201dGuidance on Clinical Evaluation (MDR) \/ Performance Evaluation (IVDR) of Medical Device Software\u201d https:\/\/health.ec.europa.eu\/system\/files\/2020-09\/md_mdcg_2020_1_guidance_clinic_eva_md_software_en_0.pdf<\/a>.<\/p>\n

\u2022\tMDCG 2019-11\u201dGuidance on Qualification and Classification of Software in Regulation (EU) 2017\/745 \u2013 MDR and Regulation (EU) 2017\/746 \u2013 IVDR\u201d, https:\/\/health.ec.europa.eu\/system\/files\/2020-09\/md_mdcg_2019_11_guidance_qualification_classification_software_en_0.pdf<\/a>.<\/p>\n

\u2022\t\u201dSR EN ISO 14155 \u2013 Clinical investigation of medical devices for human subjects \u2013 Good clinical practice.<\/p>\n

\u2022\tISO 20 916 \u2013 In vitro diagnostic medical devices \u2013 Clinical performance studies using specimens from human subject – Good study practice\u201d.<\/p>\n

Medicinal product \u2013 medical device combinations<\/strong><\/p>\n

There are various types of medicinal product-medical device combinations, as referred to in the MDR \u2013 Article 1 (9), Art. 117 and in the IVDR \u2013 Articles 2, 4, Annex II.<\/p>\n

An eloquent description of these, as well as recommendations for enforcement of legal provisions can be found in the following documents made available by the European Medicines Agency (EMA):<\/p>\n

\u2022\tQuestion-and-answer guidance on the implementation of these Regulations is available below, available online at https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/medical-devices .<\/p>\n

\u2022\tQuestions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017\/745 and (EU) 2017\/746), available online at https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu\/745-eu-2017\/746_en.pdf<\/a>.<\/p>\n

\u2022\tMDCG 2022 \u2013 5 \u201dGuidance on borderline between medical devices and medicinal products under Regulation (EU) 2017\/745 on medical devices\u201d available online at https:\/\/health.ec.europa.eu<\/a>.<\/p>\n

Clinical trials for medicinal product \u2013medical device combinations shall be submitted to the NAMMDR Clinical Trials Directorate (DSC). As the case may be, the DSC will either consult the DGDM for medical device documentation or the sponsor will have to submit in parallel an application for notification of the medical device of the combination to the DGDM. In most cases of medicinal product-medical device combinations, the latter (whether they are medical devices or in vitro diagnostic medical devices) must bear the CE marking.<\/p>\n

Useful contacts:<\/p>\n

dscdm@anm.ro<\/a>, for SAE reporting as well<\/p>\n

dsc@anm.ro<\/a>, for clinical trials on medicinal products and combinations with medicinal products<\/p>\n","protected":false},"excerpt":{"rendered":"

Clinical investigations with medical devices and evaluation of the performance with in vitro diagnostic medical devices A \u2018clinical investigation\u2019 is […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":469,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4800","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/4800","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=4800"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/4800\/revisions"}],"predecessor-version":[{"id":9579,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/4800\/revisions\/9579"}],"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=4800"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}