News about GMP/cGMP

28.05.2021

EC: EU MDR in force along with Q&A

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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