One month after members of the European Council expressed support for delaying the Medical Device Regulation (MDR, 2017/745) transition period in a meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), the European Commission on 6 January 2023 adopted a proposal to allow medical device manufacturers more time to complete certification of their devices to the new regulation, following concerns by EU regulators and industry that shortages of lifesaving products were likely to occur without action. The proposal would also repeal the ‘sell-off’ date provision under both MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746).
Under the proposal, the transition period deadline would be extended from 26 May 2024 to 31 December 2027 or 31 December 2028, depending on the risk class of the device. Higher-risk devices would be subject to the shorter transition period, while lower risk devices would have until the end of 2028 to complete conformity assessment. Certain limitations are included in the proposal, however, such that only devices that are safe and for which manufacturers have already taken steps to transition to the MDR will benefit from the additional time.
The Commission explained that elimination of the sell-off period would reduce the risk of shortages by allowing devices and IVDs that were already on the market based on compliance with the preceding directives to remain on the market.
The proposal now needs to be adopted by the European Parliament and the Council through an accelerated co-decision procedure.
In addition to publishing the proposal, the Commission has also provided a press release summarising the proposals, a ‘fact sheet’, and a Q&A web page.