EU MDR transitional period to be extended

By
Wendy Levine
-
December 9, 2022
EU MDR transitional period to be extended

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:

  • An extension of the transitional period, allowing medical devices to continue to be marketed under MDD certifications through 2027 for class IIb and class III devices, 2028 for class IIa and class I devices that require an external conformity assessment, and 2028 for class 1 devices that are sterile or have a measuring function.
  • An extension of the validity of certificates issues under the MDD.
  • Some restrictions will be put in place under the new extensions. Devices not eligible for extended deadlines will include those devices presenting an unacceptable risk, those that have undergone significant changes since being certified, and devices for which the manufacturers are already in the process of obtaining certification under the MDR.
  • The removal of the existing “sell off” provision.

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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