The Council of the European Commission has concluded their December 9th meeting meant to address member states’ concerns over the challenges and issues in meeting current MDR deadlines. MDD certificates for medical devices will continue to be accepted for an additional three to four years beyond current MDR deadlines, with limited exceptions.
While not all details are available, it is believed that the following changes will be adopted:
It is expected that the MDCG will release a guidance to address bridging the gap for expiring MDD certificates within the coming days and that the full legislative proposal will be introduced in January, 2023.
Stay tuned for additional information as we learn exactly how this will be implemented and what restrictions will be in place.
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