After a one-year delay due to the COVID-19 pandemic, the Medical Device Regulation (MDR) application process that began on 26 May 2021 and was expected to be in full effect by 26 May 2024, has reached another roadblock in its implementation. The EU Commission has issued an MDR draft proposal, endorsing the extension of the transition period of medical devices based on their risk classification, shifting the timeline to either 2027 (Class III and Class IIb) or 2028 (Class IIa and I).

Among the reasons for this proposal is the ripple effect that has resulted throughout the EU market due to a stricter regulatory framework of the MDR, causing the re-classification and re-certification of certain medical devices already in the market. Additionally, the lack of notified bodies (NB) across the EU to review MDR applications has added to the struggle with the high cost and long wait times, slowing the process of getting new devices into the market.

This has left manufacturers, especially small to medium-sized enterprises, in a conundrum of temporarily reducing their medical device portfolio to comply with the MDR deadline. A risk of reduced access to life-saving devices may result in compromising MDR’s main objective of patient safety.

Will the extension period be enough to allow manufacturers to take action for the re-certification of their products? Or would there be a continuing cycle of further extensions as more CE certifications under the Medical Device Directive (MDD) are set to expire throughout the transition period? Would there be enough resources to prevent product shortages?  The overwhelming pressure on manufacturers and NBs to provide a seamless transition in their respective roles during the transition period has for now lessened as they’ve gained more time, but the risk of product shortages still looms ahead in a race against time for certification. 

References:

Most recent news:

https://www.med-technews.com/api/amp/medtech-insights/medtech-regulatory-insights/regulation-for-medical-devices-recent-developments-explained/

Proposed draft extension:

https://cdn.ymaws.com/www.medicaldevices.org/resource/resmgr/international_wg_docs/01.10.23_mdr_proposal.pdf

Other references used:

https://www.fiercebiotech.com/medtech/eu-commission-moves-forward-proposal-delay-mdr-implementation

https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_24

https://www.bechbruun.com/en/news/2022/eu-council-decides-to-postpone-the-mdr#:~:text=The%20EU%20Commission%20together%20with,MDR%20will%20also%20be%20undertaken.