The European Commission intends to extend the transition period under the Medical Devices Regulation (MDR, 2017/745) for an additional three years. The proposal was raised at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council meeting on 9 December 2022 by the European Commissioner for Health, Stella Kyriakides, and supported unanimously by the member states present.
The issue of MDR deadline extension had been strongly lobbied for by MedTech industry representatives for many months amid concerns about the number of devices yet to transition to the MDR, along with the rising costs of recertification and significant notified body assessment backlogs. It is estimated that around 23,000 EC notified body compliance certificates have not yet transitioned, most of which will expire on 26 May 2024, creating a new bottleneck and further associated delays.
The main proposals can be summarised as follows: the relevant transition periods for medical devices cleared under the Medical Device Directive (MDD, 93/42/EEC) will now apply until May 2027 (for Class III and IIb devices) and May 2028 (for Class IIa and I devices). However, only devices that are “safe” will be able to benefit from the extension. Further, it is likely that manufacturers must have actively started the MDR transition process to benefit. Finally, the one-year ‘sell-off’ period, that was due to end on 26 May 2025, has been eliminated, thus devices that comply with the MDD or AIMDD can continue to be made available on the market and put into service with no sunset date, once they have been placed on the market.
On the same day, the Medical Device Coordination Group (MDCG) published a position paper on the potential use of MDR Article 97 by member states to allow MDD-compliant, but MDR non-compliant, devices onto their local markets, which includes similar limitations as to eligibility as the Commission’s deadline extension proposal. The title of the paper is ‘MDCG 2022-18: MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate’. The document includes the draft of a two-page checklist for eligibility.
The Commission has indicated that legislation to bring these proposals into effect will be placed before the Council of the EU and the European Parliament in early 2023.