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Medtech Biggest Casualty In Swiss/EU Uncertainty As Worst-Case Scenario Looms

 
• By Amanda Maxwell

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.

Switzerland_EU_Signpost

Future trade in medical devices and in vitro diagnostics (IVDs) between Switzerland and the EU, and, this year at least, with the UK too, is now under serious threat. This is because there has still been no resolution to the problems caused by political uncertainties between the EU and Switzerland in the context of the Institutional Agreement (InstA), the basis for the future relationship between the EU and Switzerland. This is the situation with fewer than than 100 days to go until the full application of the EU’s Medical Device Regulation (MDR).

Experts in Switzerland are now fearing the outcome of the political uncertainties will be more severe than had been imagined, and could lead to a complete breakdown in the

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