EC: EU MDR in force along with Q&A
Finally the date has come: as of 26 May 2021 the EU rules on medical devices (EU MDR) entered into force. Following a one year postponement due to COVID-19, this regulation is considered a big step forward to improve the safety and quality of medical devices. There are, however, still plenty of uncertainties for their manufacturers, but there is also a saying that every journey begins with single steps.
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
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