EU Regulatory Round-Up, February 2023: EU Closes In On Adopting MDR Proposal

The European Commission’s legislation to extend compliance deadlines for legacy devices under the Medical Device Regulation has remained top of the agenda for the second month running after it was given the formal go-ahead by the European Parliament in February.

The EU is just a stone’s throw away from formally adopting laws that will postpone Medical Device Regulation compliance transition deadlines and remove the sell-off period for both the MDR and In Vitro Diagnostics Regulation after a 16 February vote by the European Parliament in favor of the proposal, which was published in early January.

The new measures are intended to go some way towards addressing capacity issues being experienced by notified bodies, and the...

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