Following the Council's agreement on the new measures to implement the Medical Devices Regulation (MDR), the Medical Device Coordination Group (MDCG) published a position paper on the application of article 97 in December 2022. Article 97 addresses non-compliance of medical devices and consequent related actions of the Member States. Specifically, this Paper (namely MDCG 2022-18) focuses on the application of Article 97 of the MDR to legacy devices for which the Directives' certificate expires before . . .
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