On January 6, 2023, the European Commission submitted a proposal for a Regulation (2023/0005) This initiative aims to gradually extend the transition period for medical devices and in vitro diagnostic medical devices. It also aims to abolish the 'sell-off' deadline after which devices would have to be withdrawn. This applies to devices placed on the market before or during the transition period and still in the supply chain.
The Commission considers that, despite considerable progress over the past years, the overall capacity of notified bodies remains insufficient to carry out the tasks required of them, namely to assess the conformity of the devices to the regulation. In addition, many manufacturers are not yet sufficiently prepared to meet the strengthened requirements of the MDR by the end of the transition period. This is threatening the availability of medical devices on the EU market and the safety of European patients.
The Commission proposes to amend the following points:
Extend the transitional period from 26 May 2024 to 31 December 2027 for high-risk devices (class III and class IIb implantable devices) and 31 December 2028 for medium and low-risk devices, subject to specified circumstances.
Delete the current ‘sell-off’ date (27 May 2025) in Article 120(4) MDR. Consequently, devices placed on the market before the end of the transition period can be made further available on the market without a legal time restriction.
The Blood Transfusion Association (BTA) welcomes the Commission’s recognition of the urgent risks of medical device shortages in Europe stemming from the challenges posed by the transitional provisions in the Medical Devices Regulation.
In this sense, the BTA:
Welcomes the proposed transition periods that would enhance the notified bodies’ capacity, the access to notified bodies and the manufacturers’ preparedness, as well as it would help to avoid potential shortages of medical devices.
Aligns with the European Commission’s proposal to delete the current ‘sell-off’ date, as it contributes to avoiding a disruption of the supply of medical devices on the EU market and prevents unnecessary disposal of safe medical devices that are already on the market but not yet with the patients that need them.
Proposes the synchronisation of the extension provided on the Medical Device Regulation and the sunset date for DEHP in medical devices envisaged in the REACH regulation.
You may find BTA’s complete submitted response in this link.