Along with the announcement, the European Commission (EC) issued a Q&A document on the application of MDR.

The document summarizes

• the many patient benefits from a new approach for medical device oversight
• delineates which products are affected by the new regulation and in what way
• general information on the validity of products certified under the old scheme for which a transitional period is granted until May 2024, or
• the role of the Notified Bodies and the state of play on EUDAMED

With the content being held rather general resembling a basic overview, it is noted, that some MDR provisions will not be in place until 2025, to allow a smooth transition. The regulation for in vitro diagnostic medical devices will enter into force on 26 May 2022.

Source:

EC: Press Corner