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The European Parliament has adopted the proposal to extend the transitional period for legacy devices (i.e. those covered by a certificate or declaration of conformity issued under Council Directives 90/385/EEC or 93/42/EEC before the date of application (DOA) of the MDR 2017/745, May 26th, 2021. The goal of this extension is to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework.
However, it’s important to note that they also set specific conditions manufacturers need to adhere to. We made an overview of the extended transition periods and listed the conditions that need to be fulfilled.
Extended transition periods
Extension of validity of certificates
MDD 93/42/EEC or AIMDD 90/385/EEC certificates that were valid on the date of application (DOA) of the MDR (May 26th 2021) can be placed on the market until the dates outlined in the table if all above conditions are met.
MDD 93/42/EEC or AIMDD 90/385/EEC certificates that already expired before this amendment comes into force have an additional condition to fulfil. They remain valid until the dates outlined in the table above only if one of the following additional conditions is fulfilled:
Furthermore, the ‘sell-off’ date is removed. This deletion applies to both medical devices and IVDs. The ‘sell-off’ date is the end date after which devices that have already been placed on the European market, and remain available for purchase, should be withdrawn. Removing this ‘sell-off’ date will ensure that safe and essential medical devices that are already on the European market remain available to healthcare systems and to patients in need.
This amendment gives Notified Bodies more time to assess the conformity of MDD and AIMDD devices while manufacturers can continue placing their legacy devices on the market. Manufacturers however, still need to have their QMS and Technical Documentation compliant with MDR requirements before 26 May 2024. As this is the date they need to provide the Technical Documentation to the notified body as part of the formal application for conformity assessment.
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