Designation Of EU Notified Bodies: Is There Evidence Of Bias?
With the EU having now announced 20 notified body designations against the EU’s Medical Device and IVD Regulations, some clear patterns have emerged. But the Commission denies any bias.
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With just 98 days until the full application of the Medical Devices Regulation, the European Commission’s target of having 20 notified bodies designated has nearly been reached.
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.
Growing evidence demonstrates the one-year delay to the Medical Device Regulation, plus the expansion of the scope of products that could remain on the market beyond the MDR date of application, have simply pushed problems to 2024.