No MRA Means Switzerland’s Seamless IVDs Trade With The EU Is At An End
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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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-two documents have been posted on the tracker since its last update.
Regulation, Digitization Mulled As Swiss Medtechs Look To An ‘EU+’ Vision For The Future
With Switzerland now operating as a third country to the EU, Swiss-based medtech manufacturers are keen to maximize their inherent advantages and build a basis for future growth.
EU IVDR Amending Regulation Published And Staggered Grace Periods Now Official
The text amending the IVD Regulation, taking the pressure of the entire sector, has now been officially published. But clarification is needed regarding timelines for compliance for in-house IVDs.