Switzerland continues with its own Swiss Medical Device Regulation (MepV).
As is widely known, Switzerland will soon be going its own way in terms of medical device regulation. A bilateral agreement for medical devices, as it existed in MDD times between Switzerland and the EU and simplifying the exchange of goods, will cease to exist from May 26th, 2021. Europe continues with the Medical Device Regulation (MDR), Switzerland continues with its own Swiss Medical Device Regulation (Medizinprodukteverordnung, MepV).
Examples of specifications in the Swiss regulations for medical devices include:
Article 13 Conformity mark and identification number.
„Products placed on the Swiss market or made available on the Swiss market must bear a conformity mark in accordance with Annex 5 MepV. The conformity mark listed in Annex V EU MDR is also permissible as a conformity mark.”
Article 51 Obligations
„If the manufacturer is not domiciled in Switzerland, their products may only be placed on the market if he has authorised a person domiciled in Switzerland. The mandate must be agreed in writing.“
Article 51 in particular will cause costs and regulatory problems. As with the UK, manufacturers will also have to appoint an authorised representative in Switzerland in the future. Since this will affect European manufacturers quite soon, transition periods have been planned. Conversely, and this has already been reported, Swiss medtech companies will now need a European Authorised Representative as of May 26th, 2021. We hope that this tiresome chapter will soon come to an end and that unity will once again prevail. However, the Swiss MedTech Association does not expect a quick solution.
See the Swiss MedTech news ticker for further details.