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EU Council to postpone the MDR deadlines

On 9 December 2022, the EU Council decided to support a proposal to postpone the MDR deadlines. The current deadlines have sparked concern that widespread shortages of medical devices could be the result if the deadlines are left in place. The commission’s plan would not automatically apply an extended transitional period for all the medical devices, but the extension would be allowed on the condition that it is critical for the safety of the patients. Commission and the EU Council will move forward with an amendment in the beginning of 2023 to extend the MDR deadline.

The new proposal for MDR deadlines are:

  • 2027 – Class III and IIb devices
  • 2028 – Class IIa and I devices (i.e. lower risk devices) that need the involvement of a notified body in the conformity assessment

Extension applies only to devices that:

  • do not present any unacceptable risk to health and safety,
  • have not undergone significant changes in design or intended purpose
  • the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR, such as adaptation of their quality management system to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body.

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