{"id":11030,"date":"2023-10-24T08:00:01","date_gmt":"2023-10-24T05:00:01","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11030"},"modified":"2025-08-14T08:35:02","modified_gmt":"2025-08-14T05:35:02","slug":"important-notification-24-10-2023","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-24-10-2023\/","title":{"rendered":"Important notification"},"content":{"rendered":"

24.10.2023<\/strong>
\nTo the attention of healthcare facilities and all interested parties<\/strong><\/span>
\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.
\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.
\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.
\nThus, with respect to the NAMMDR viewpoint no. 112327E\/06.06.2023, we hereby make the following clarifications:
\nThe viewpoint expressed in the aforementioned NAMMDR notice refers to the document “System user Guide” 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.
\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).
\nLink:
\nhttps:\/\/www.medtronicdiabetes.com\/sites\/default\/files\/library\/download-library\/user-guides\/guardian-connect-v3_2\/us-manual.pdf<\/a>
\nThe \u201dSystem user Guide\u201d:
\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;
\n\u2013 does not bear the CE marking, applicable in the European space;
\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.
\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.
\nThis device has been subject to conformity assessment procedures appropriate to the device\u2019s class, with the involvement of the notified body GMED France.
\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.
\nOn the European market, including Romania, the system is sold with 3 manuals, for the main components, namely:
\nGuardianTM Connect<\/strong> \u2013 User Guide, with the Romanian version GuardianTM Connect \u2013 User Guide (for the transmitter);
\nGuardianTM Sensor (3)<\/strong> \u2013 User Guide (in several languages, including English and Romanian) (for the sensor).
\nGuardianTM Connect<\/strong> \u2013 Application User Guide (for the application).
\nThese manuals do not indicate age limits for the components of the blood glucose monitoring system.<\/strong>
\nBelow are the links to the user manuals, published on the MEDTRONIC Romania website:
\nhttps:\/\/resources.cloud.medtronic-diabetes.com\/sites\/prd\/files\/documents\/2022-03\/manual-guardian-connect-lock-out1.pdf<\/a>
\nhttps:\/\/resources.cloud.medtronic-diabetes.com\/sites\/prd\/files\/documents\/2022-03\/guardian-sensor-3-ifu.pdf<\/a>
\nhttps:\/\/resources.cloud.medtronic-diabetes.com\/sites\/prd\/files\/documents\/2022-03\/guardian-connect-aplicatie-32-lot-1.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

24.10.2023 To the attention of healthcare facilities and all interested parties Following the notification received from MEDTRONIC Romania SRL, regarding […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[],"class_list":["post-11030","post","type-post","status-publish","format-standard","hentry","category-anunturi-importante-dispozitive-medicale"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11030","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/post"}],"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=11030"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11030\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11030"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11030"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11030"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}