EU Regulatory Roundup, January 2020: Deluge Of Challenges Created By Brexit And MDR Problems
Brexit could hardly have come at a worse time for the medtech sector in Europe. The implementation of the new medtech regulations is behind schedule, and threatening the survival of many medtech products. Now the UK is looking at its own regulatory route. Will this mean regulatory divergence?
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With fewer than a hundred days left before the EU Medical Device Regulations kick in, Medtech Insight’s executive editor Ashley Yeo and managing editor Amanda Maxwell discuss in this week's podcast growing concerns by medtech industry members that they may not be ready in time to comply with the regulations and may inadvertently run afoul of them.
What will the fall-out of political tensions between the EU and Switzerland mean for notified bodies based in Switzerland, and for the future recognition of CE marks granted in one of the most important medtech markets in Europe?
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.