EU Regulatory Round-Up, January 2023: Cautious Optimism As New MDR Proposal Unveiled

All eyes were on the European Commission in January as it edged closer to adopting new legislation that will see the Medical Device Regulation transition deadlines extended.

The new year began with a flurry of excitement among those active in the EU medtech sector. The European Commission, true to its promises at the meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) in December, published its official proposal to extend compliance deadlines for the MDR on 6 January.

High risk devices (class III and class IIb) will now have until 31 December 2027 to comply with MDR rules...