European regulation on MD - France requested to extend the transitional period

Yesterday, France requested the European Commission officially extend the EU MDR's transition period. The document highlights it is impossible for the Notified Bodies to review all remaining files of the products yet to be certified.

 Robert Paassen, MDR Lead: “This announcement comes shortly after the publication of the MDCG 2022-14, in which the European Commission tries to smoothen the leftover transition process as good as possible. I think this is an important and necessary step by a national authority to guarantee the availability of the medical devices in Europe.”.

Download the official document below.

Robert Paassen
Post date: September 23, 2022
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