Regulation, Digitization Mulled As Swiss Medtechs Look To An ‘EU+’ Vision For The Future
Swiss Parliament addresses proposal to allow US FDA-approved products onto the market
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.
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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.
The trend among device innovators to focus on diagnostic technologies that improve imaging, offer better visualization of tissues and avoid the need for biopsies is well noted by full-service law firm CMS. Its equIP program supports many start-ups incorporating AI into products and development processes.
Forum officially unveiled on 19 February to represent growing band of organizations designated against the UKCA mark.