This proposal provides:
1) An extension of 2.5 years under conditions of the transition period for devices benefiting from transitional provisions.2) An obligation to notify authorities, the supply chain and customers of the discontinuation of the marketing of a device at least six months in advance when such interruption could result in serious harm to patients or public health in order to help customers and authorities anticipate and manage shortages.3) The possibility of making the use of certain EUDAMED modules compulsory earlier than currently planned (the timetable remains to be determined depending on the modules, and it is possible that the use of certain Eudamed modules ( the first to be finalized) is mandatory from Q4 2025).
The proposed 2.5 year extension would be subject to conditions:a) The legacy device still complies with Directive 98/79/ECb) It has not undergone any significant change in design or destinationc) It does not pose an unacceptable risk to the health and safety of patientsd) The manufacturer has implemented a quality management system in compliance with the IVDR before May 26, 2025.e) The manufacturer has submitted a conformity assessment file before May 26, 2025 for classes D, May 26, 2026 for classes C, May 26, 2027 for class B and class A Sterile.f) Files submitted before the deadlines in point e) are the subject of a contract signed between the ON and the manufacturer before September 26, 2025 for classes D, September 26, 2026 for classes C, 26 September 2027 for class B and class A Sterile.
Under these conditions, the deadlines for the end of the transition and therefore for obtaining the certificates would be December 31, 2027 for classes D, December 31, 2028 for classes C, December 31, 2029 for class B and class A Sterile.
Please note: this is a proposal, there is no guarantee at this stage that these proposals will become applicable. These proposals will follow an urgent process of political approval within the Council and the European Parliament with a view to their possible inclusion in law. We will keep you informed of all past milestones.
