UK And Swiss Notified Bodies Announce Bad News For Clients
The UK is about to lose most of its medtech notified body offering, as its remaining notified bodies reveal plans to migrate certificates to the EU27 in a rescue bid, given the impact of a potential no-deal Brexit. In Switzerland, too, there has been bad news for notified body clients.
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Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.
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.