EU Regulatory Roundup, February 2019: Brexit Overwhelmingly Dominates EU Medtech Focus
With less than four weeks to go until the UK is due to leave the EU, seven of Medtech Insight's top 10 EU regulatory stories in February focused on what will happen if the UK leaves without a deal – a possibility that has been looking increasingly likely.
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It seems to be game over for anyone who might have been hoping the European Commission would do a U-turn on its decision to use the Italian CND nomenclature as the basis for communication in Eudamed, instead of the well-established GMDN. But GMDN is strong in its resolve to remain a vital global nomenclature service.
2020 is not getting off to a good start for manufacturers needing to comply with the EU’s new Medical Device Regulation on 26 May 2020. The European Commission’s latest document seems to confirm industry’s fears about the ability of the EU’s medtech system to be ready in time.
December 2019 was a big month for far-reaching EU medtech regulatory developments that will have a significant impact on the way and speed of implementation of the Medical Device Regulation.