News about GMP/cGMP

30.03.2020

MDR: Proposal for a delay due to Covid-19

The deadline of 26 May 2020 should have been the date: The European Commission's Medical Device Regulation (MDR) was supposed to come into force. Due to the Corona crisis, the European Commission is now submitting a proposal to postpone the implementation deadline.

Other organisations had already called for this step:

Medical device manufacturers have repeatedly questioned whether the deadline can be met, as there is still a lack of Notified Bodies. The introduction of laws to ensure compliance with the new product standards was also critical in terms of timing (we reported).

In a press release of 23 March 2020, MedTech Europe called for a postponement of the introduction date for MDR and IVDR. Their proposal: Six months after the crisis has been overcome, the implementation should be resumed.

In a letter of 24 March 2020, six Members of the European Parliament address the lack of resources caused by the current crisis in the following areas:

  • Approval of clinical trials
  • Notification and auditing of Notified Bodies
  • Manufacturing

The Members of Parliament are calling to maintain the current system for regulating medical devices. Health systems across Europe need all their resources to deal with the corona crisis.

The proposal for postponement should be submitted in early April and implemented as soon as possible. This information is according to a Q&A session at the European Commission press conference of 25 March 2020.


Sources:

MedTech Europe: Press release

European Commission: Letter of the European Parliament

European Commission: Q&A Press conference Covid-19 and MDR

 



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