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No MRA Means Switzerland’s Seamless IVDs Trade With The EU Is At An End

Executive Summary

The EU’s full implementation of the In Vitro Diagnostic Regulation on 26 May has put the Swiss IVD industry on a "third country" footing with the EU, as happened in 2021 for medical devices. The two parties’ mutual recognition agreement for all medtech products has ceased to apply. A renewed MRA is not likely for several years.

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