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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Despite COVID-19 distancing measures and fears that new notified body appointments would grind to a halt, there is now a new notified body for the EU Medical Device Regulation.
Many medtech companies are ready to demonstrate compliance with the EU MDR, but COVID-19 notified body auditing restrictions have brought their plans to a halt. The EU is trying to break the impasse.