On 16 February 2023, the EU Parliament extended the deadlines for certifying medical devices under the European Medical Device Regulation (2017/745, “Medical Device Regulation”—MDR) to prevent massive bottlenecks in the certification process and to mitigate the risk of shortages.

The new deadlines are staggered based on their risk level: For high-risk products, such as pacemakers or hip implants, the deadline was extended from 26 May 2024, to 31 December 2027. For medium- and low-risk products, such as syringes or surgical instruments, the deadline will be 31 December 2028.

The MDR entered into force on 5 April 2017 and became effective on 26 May 2021. It replaced two directives on medical devices (93/42/EEC, “Medical Device Directive”) and active implantable medical devices (90/385/EEC, “Active Implantable Medical Devices Directive”). 

Medical devices approved under Medical Device Directive regulations can no longer be grandfathered in under the new MDR but must be certified under the new requirements. In this regard, Art. 120 of the MDR standardizes transition periods. The length of the transition period is determined by the risk class of the respective medical device and certifications that exist under the previous law. 

Originally, Art. 120 (2) of the MDR provided that current “approvals” of class IIa, IIb and III devices classified under the old law, which took place before 25 May 2017, should continue to apply until the date specified in the certificate. Since a certificate can be issued for a maximum of five years, the latest expiration date is 27 May 2022. Certificates issued after 25 May 2017, will expire on 27 May 2024, even if the date on the certificate is a later date.

Due to both the considerable time and effort needed by companies to implement these changes as well as a certain vagueness in interpreting the MDR, the European Commission adopted a proposal on 6 January 2023 (the proposal and information about it can be viewed on the homepage of the European Commission under the section Extension of the transition periods provided for in the regulations”), according to which the transition periods are to be extended. The latest deadline, 31 December 2028, would then apply to Class I devices (e. g. Class Ir devices: reusable surgical instruments), for which a notified body must be involved under the MDR. The transition periods relate to the placing of the device on the market and putting it into service, but not to the sale. The “sell-off date” rule, i.e., the end date after which devices already on the market but not with the end user must be withdrawn from the market, has been omitted entirely.
In view of the individual case-dependent classifications, you are welcome to contact our Life Sciences team in Germany should you have any questions.