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EU Council Adopts MDR/IVDR Amendment Proposal

 
• By Eliza Slawther

The EU Council has adopted proposed changes to the EU Medical Device Regulation that will see transition deadlines extended for legacy devices. This completed final legislative step means that the amendments are set to enter force in around a week’s time, on 15 March.

The European Commission’s proposals to extend the transition deadlines for legacy products in the context of the Medical Device Regulation and remove the sell-off date for products under both the MDR and In Vitro Diagnostics Regulation were adopted formally by the EU Council during a meeting on 7 March.

The unanimous vote by all 27 member states took place during a meeting of the Council of the European Union...

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