What You Need to Know About Clinical Evidence For The EU IVDR
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
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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.
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.
The EU’s IVD industry and European Commission are poles apart in their views on delaying the IVD Regulation implementation date. There is growing alarm in the sector.