EU Regulatory Roundup, September 2020: Uncharacteristically Slow As COVID-19/Brexit Wreak Havoc
European Commission medtech news all but dried up in September. But the UK’s Brexit news and implications for medtech has given EU and UK medtech stakeholders enough to ponder.
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The European Commission is wavering as pressure builds for it to allow initial audits to be performed virtually under the Medical Device Regulation.
With growing urgency for the IVD industry to start compliance with the IVD Regulation, NSF’s Robyn Meurant explains the importance of getting clinical evidence right first time
There is no choice: manufacturers must start EU MDR compliance now, however incomplete implementation is. And some MDR clauses apply to all products as of May 2021, regardless of the grace period.