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

 
• By Ashley Yeo

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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The European Commission’s directorate-generals for health and food safety, and trade, this week issued a notice to stakeholders on the new trading arrangements for Swiss-EU cross-border trade in in vitro diagnostics (IVDs).

The notice was released to mark the end of the mutual recognition agreement (MRA) between the two economic areas in IVDs. That followed the full implementation – albeit with extended...

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