Medical Devices système à appréhender ces subtilités, la Commission européenne a publié, en plus des 1 500 pages de guidelines, des « Questions-réponses », qui ont déjà fait l’objet d’une première révision, ainsi qu’une fiche de synthèse desti- née, notamment, aux pays hors Union européenne. Elle veille, par ailleurs, à travers diverses enquêtes, que tous les moyens de communication nécessaires aient bien été mis en œuvre autour de ces sujets. L’institution européenne a également lancé deux études : l’une sur le monitoring de la disponibilité des DM pendant la période de transition et l’autre sur la gouvernance réglemen- taire et l’innovation dans le domaine des DM, qui devrait se terminer fin 2024. Rachelle Lemoine Les acteurs du marché pourraient se 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 appels de lots, plus rapidement et plus efficacement. Market players could find themselves under pressure more quickly since, at the end of last year, EU member states put pressure on the Commission to speed up the introduction of Eudamed and make it compulsory, so as tobe able to respond with any recalls for batches more quickly and efficiently. in particular, comply with the directives,products placed on the market will havecommunication have been deployed in not undergo any significant change into comply with the regulation, with therelation to these issues. The European their purpose or design, and not presentexception of those in distribution chan-institution has also launched two stu- any unacceptable risk to the health ornels or on users' premises, which willdies: one on monitoring the availability safety of users. In addition, the manu-be considered as having been placedof medical devices during the transition facturer must undertake to have set upon the market and may continue to beperiod, and the other on regulatory its quality management system in com-used. In addition to the 1,500 pages ofgovernance and innovation in the field pliance with the regulation before Mayguidelines, the European Commissionof medical devices, which should be 26, 2024, and to have submitted allhas published "Questions & Answers",completed by the end of 2024. these formal applications to its notifiedwhich have already been revised, as well body before May 26, 2024, and to haveas a summary sheet designed in particu- signed the contract with the notifiedlar for countries outside the European Rachelle Lemoine body by September 26, 2024. Union. Through various surveys, it also Ultimately, by the end of 2028, allensures that all the necessary means of 54 The Pharmaceutical Post 17 / Janvier - 2024