Proposal Pending at European Commission to Delay MDR Deadlines: More Time to Certify Medical Devices to Mitigate Risk of Shortages

On January 6th 2023, The European Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation.  
 
The new deadlines depend on the medical devices’ risk class and will ensure continued access to medical devices for patients. It will also allow medical devices placed on the market in accordance with the current legal framework and that are still available to remain on the market (i.e., no ‘sell-off’ date). 
 
There are more than 500,000 types of medical devices on the European market. The proposal intends to address the risk of shortages of medical devices on the EU market due to the new MDR regulations and capacity shortages of notified bodies.  

 

Key elements of proposal

  • For medical devices covered by a certificate or a declaration of conformity issued before 26 May 2021, the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices. The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the Medical Devices Regulation will benefit from the additional time.

 

  • The proposal introduces a transition period until 26 May 2026 also for class III implantable custom-made devices, giving their manufacturers more time to obtain certification by a notified body. Also in this case, the transition period is subject to the application of the manufacturer for a conformity assessment of devices of this type before 26 May 2024.

 

  • To reflect the transition periods put forward by these amendments, the proposal extends the validity of certificates issued up until 26 May 2021, the day when the Medical Devices Regulation became applicable.

 

  • The Commission also proposes to remove the ‘sell-off’ date currently established in the Medical Devices Regulation and in the In Vitro Diagnostic Medical Devices Regulation. The ‘sell-off’ date is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn. Removing this ‘sell-off’ date will ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need.

 

The extension of the MDR does not mean you can wait with complying until the deadline. During this period your devices will fall under legacy devices and will still need to comply with importer obligations and others. We highly recommend to continue your efforts and apply at a notified body as soon as possible due to the significant queues. 

 

Relevant documentation and links

 

 

 

The next steps will be that the European parliament will evaluate the proposed regulation in the coming weeks through an accelerated co-decision procedure to whether or not adopt this MDR extension proposal.

 

Want to learn more about your specific situation and how we can help or would you like to learn about the experience of our clients? Book a call with us or contact us at info@growthimports.eu 

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