Allegations Of EU Notified Body Fees Having Escalated And Of Being Unpredictable
US medtech companies are worried EU notified bodies have too much freedom over setting their fees, accusing them of lacking transparency and being inconsistent with what they charge. They also allege that notified body practices mean some products will miss the four-year grace period.
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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.