EU 2020 MDR Guidance Notes For Class I Manufacturers

There will be no transition period for Class I medical devices which remain in Class I under MDR. From 26th May 2020 onwards, the conformity for Class I medical devices which are not subject to up-classification has to be declared according to MDR and thus all requirements of the MDR have to be fulfilled.

Click here to access the “Guidance notes for manufacturers of Class I medical devices” under MDR published by the Medical Device Coordination Group (MDCG).

Source: MedNet GmbH

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