The European Council (EC) has approved a measure to extend the transition period for medical devices under the Medical Devices Regulation (MDR, 2017/745) and to remove the sell-off provisions for existing products as required under MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746).
On 7 March 2023, the Council voted 27-0 to adopt the measure put forward by the European Parliament and Commission. The parliament voted 537-3 on 16 February 2023 to push back the MDR transition period to avoid potentially forcing tens of thousands of products off the market in the EEA.
“Today we have agreed on measures that will allow the industry to continue bringing essential medical devices to the market and ensure that patients have safe access to medical devices,” Acko Ankarberg Johansson, Swedish minister for health care, said in a press release.
The measure had already been approved by the European Commission on 6 January 2023. With the looming MDR transition deadlines coming up in the next few years, stakeholders have raised concerns about the supply of medical devices, notified body capacity and manufacturer preparedness, which prompted the move to extend the transition period.