With this proposal, the European Commission has put a crucial spotlight on the plight of medical device manufacturers: An extended transition period of the MDR transition by several years was demanded, among others, by EU Commission Vice-President Margaritis Schinas a few weeks ago. Now the Council of the European Union made a decision: On 7 March, they accepted the proposal.
This not only gives manufacturers more time to certify new medical devices according to MDR. Bottlenecks in supply could also be avoided, according to the basic idea.
“With the extension of the MDR transition, the approval backlog at the Notified Bodies can finally be equalized,” says Alfred Koch, CEO at BAYOOCARE.
“My advice for manufacturers is, despite the expected relief, to promptly transfer the existing products to the MDR. This way, you can make the best possible use of the transition period to bring your technical documentation up to date in terms of the essential safety and performance requirements.”
At a glance: These deadlines will soon apply to products
One condition: The certificate for the conformity assessment procedure must have been issued before 26 May 2021.
What happens next?
After the approval by the European Council, a formal adoption of the requirements is expected to follow on 15 March 2023. After publication in the Official Journal, the new regulation can enter into force the following day.
