European Commission’s Missed Deadlines And Contingency Planning: Welcome To 2020!
2020 is not getting off to a good start for manufacturers needing to comply with the EU’s new Medical Device Regulation on 26 May 2020. The European Commission’s latest document seems to confirm industry’s fears about the ability of the EU’s medtech system to be ready in time.
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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.