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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Eighteen years of free trade threatens to come to a sudden stop, as a result of the stalemate in the market access agreement between Switzerland and the EU. Industry association Swiss Medtech is advising local medtech manufacturers to find notified bodies and authorized representatives based in the EU. However, local company SQS remains confident of its ongoing notified body role.
The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.
With just a few months remaining until the full application of the EU Medical Device Regulation, notified body designations are still only trickling through. Ireland is the latest EU member state to have a resident MDR notified body.