At the EPSCO Council meeting last Friday 9 December, the EU Commission presented a legislative initiative to urgently amend the MDR in light of implementation delays that threaten the availability of medical devices on the market. In our summary below, our Head of Regulatory Corinne Larke outlines the context behind this initiative, the previous action taken to help with manufacturer preparedness and notified body capacity, as well as what the initiative would mean for the MDR moving forward…

The context

At the June 2022 EPSCO Health Council meeting, Health Ministers expressed concern that severe challenges related to MDR implementation posed a threat to medical device availability, and EU market access for innovative medical devices.

Called upon to urgently propose solutions, the MDCG set about tackling the immediate challenges regarding preparedness of manufacturers, and the insufficient capacity of notified bodies to certify medical devices under MDR within the remaining transition period (which currently ends on 26 May 2024).

Key action taken so far

August 2022 | MDCG 2022-14 was published, laying out 19 non-legislative actions within the current regulatory framework with a view to enhancing notified body capacity, access to notified bodies, and manufacturers’ preparedness to support a successful MDR and IVDR transition.

October 2022 | A revised MDCG 2019-6 aiming to remove obstacles to the employment of qualified personnel by notified bodies was issued. An MDCG workshop focused on defining orphan devices and overcoming regulatory challenges related to these devices also took place.

November 2022 | The MDCG agreed on a uniform approach for the use of market surveillance provisions as a bridging action before the transitional period would be extended by an amendment of the MDR.

December 2022 | The EU Commission adopted two delegated acts deferring the timing of the first complete re-assessment of notified bodies, to help improve the capacity of designating authorities and notified bodies.

What’s next for the MDR?

Whilst Member States fully support MDCG 2022-14, it’s felt that the actions outlined are still insufficient. So, a targeted legislative initiative to amend the MDR has been called for, which includes:

• an extension of the transitional period in Article 120(3) MDR with staggered deadlines depending on the risk class of the device:
  • 2027 for Class III and Class IIb devices
  • 2028 for Class IIa and Class I devices that need the involvement of a notified body in the conformity assessment
• an extension of the validity of certificates issued under Directives 90/385/EEC and 93/42/EEC by amending Article 120(2) MDR (if needed for legal / practical reasons)
• the removal of the ‘sell off’ provision in Article 120(4) MDR and Article 110(4) IVDR

Following the EPSCO Council meeting on 9 December, a legislative proposal is expected to be presented early in the new year. We’ll be continuing to monitor the situation as it unfolds, and in the meantime, our Regulatory team is on hand to answer any questions on this topic.