Open questions remain for the medical technology industry

Today’s statement from the Federal Council concerning the framework agreement draft indicates that the Swiss government agrees with much of the negotiated contract. Swiss Medtech welcomes the favourable position supporting barrier-free trade in its sector between Switzerland and the EU. Unbureaucratic access to key foreign markets is vital for the export-oriented medical technology industry – which accounts for 13.5% of Switzerland’s positive trade balance.

The crucial question for the medtech industry, however, is whether the Federal Council’s signal to Brussels will be followed by a swift update of the Mutual Recognition Agreement (MRA) for their sector. «Until a decisive yes is received from both parties, we cannot give the all-clear. For that reason, our recommendation to Swiss medical device manufacturers is to continue preparing for the requirements of a non-member state.» says Peter Studer, Head of Regulatory Affairs at Swiss Medtech.

The association is calling on the Federal Council to clarify this question quickly and to provide the necessary legal certainty. Time is also of the essence. With respect to newly regulated products, Switzerland is already in third state mode, and the industry cannot rely solely on the principle of hope. A current example is the revision proposal for the Medical Devices Ordinance, now in the hearing and examination phase. «The Federal Council’s draft will only work if the MRA is updated in time. If not, portions of the proposal will remain contradictory and inapplicable», says Studer.