Good news for manufacturers of medical devices still marketed under a Medical Device Directive (MDD) certificate:
On Friday 9 December, the European Commission proposed a further extension of the MDR transition period the EPSCO meeting in Brussels. The proposed extensions in brief:
- for medical devices with higher risk (Class III and Class IIb devices) until 2027
- for medical devices with a lower risk (Class IIa and Class I devices) until 2028.
MDD certificates are planned to be valid until the certificate’s expiration date, and the validity of the certificates can be prolonged under certain conditions:
- devices must not present any unacceptable risk to health and safety
- no significant changes in design or intended purpose
- manufacturers have adapted their quality management system to MDR
- acceptance of the manufacturer’s application for conformity assessment by a notified body.
The “sell-off” deadline for May 2025 should be removed (also for IVDR).
What are the next steps?
The European Commission is planning to provide a legislative proposal to the European Parliament in early 2023.
Also see the recent MDCG_2022-18 position paper on the “application of Article 97 MDR to legacy devices for which the MDD/AIMDD certificate expires before the issuance of a MDR certificate”. Our experts have proven experience in supporting medical device companies with the MDR transition. Contact us now and a&r will help you make a successful switch to MDR!