Medical Devices l’IUD et les informations de tous les dispositifs qu’ils mettent sur le marché européen tant que le système Eudamed n’était pas totalement opérationnel, les acteurs du marché pourraient s’y voir contraints plus rapidement depuis qu’en fin d’année dernière, les Etats membres de l’Union européenne ont fait pression sur la Commission pour qu’elle accélère la mise en service d’Eudamed et le rende obligatoire afin de pouvoir faire face à d’éventuels rappels de lots, plus rapidement et plus efficacement. 3 000 certificats émis en conformité En septembre dernier, un colloque organisé par le Snitem (Syndicat na- tional de l’industrie des technologies médicales) s’est attaché à dresser un premier bilan. Environ 3 000 certificats public,called Eudamed. of Eudamed and make it mandatory, in and more dossiers submitted to notified This database comprises six modules order to be able to deal with any batch bodies are not considered complete. In which must be filled in by MD manu- recalls more quickly and effectively. France, according to a survey carried facturers, importers or agents in order out by Snitem over the summer, 60% of to register their products and generate 3,000 certificates issued MD companies had, to date, submitted a unique identification (UDI) for each in compliance all their applications to one of the 39 one. This is made up of two distinct notified bodies currently authorized to elements: the UDI-DI for the device and assess certification dossiers. the UDI-PI for its production. Last September, a symposium orga- nized by Snitem (Syndicat national de Compliance required for all Until now, market players have been l'industrie des technologies médicales) MD placed on the market strongly encouraged on a voluntary provided an initial assessment of the basis to submit the UDI and informa- situation. Some 3,000 certificates had by the end of 2028 tion for all the devices they place on the been issued in compliance with the European market until the Eudamed regulation by the end of March 2023, In practice, the validity of certificates system was fully operational. However, but over 22,000 were still pending, issued under directives pre-existing since the end of last year, EU member according to European Commission Regulation 2017/745, and still valid states have been pressing the Commis- figures. Another observation: certifica- on March 20, 2023, is maintained. sion to speed up the implementation tion times are getting longer, and more This also applies to declarations of 52 The Pharmaceutical Post 17 / Janvier - 2024