Switzerland will continue with its own Medical Devices Ordinance (MedDO).
As is probably common knowledge, Switzerland will soon be going its own way when it comes to medical device regulation. As of 26 May 2021, there will no longer be a bilateral agreement for medical devices as there was between Switzerland and the EU in the days of the MDD (Medical Device Directive) , which simplified the movement of goods. Europe will continue with the Medical Devices Regulation ,while Switzerland will continue with its own Swiss Medical Devices Ordinance (MedDO).
For example, Switzerland has specified in its regulations for medical devices:
Article 13 Conformity mark and identification number
"Devices that are placed on the Swiss market or made available on the Swiss market must bear a conformity mark in accordance with Annex 5 MepV. The mark of conformity listed in Annex V EU MDR is also permitted as a mark of conformity.
Article 51 Obligations
"If the manufacturer is not domiciled in Switzerland, his products may only be placed on the market if he has authorised a person domiciled in Switzerland. The mandate must be agreed in writing."
Art. 51 in particular will cause costs and regulatory problems. In addition to the UK, you (manufacturers) will also have to appoint an authorised representative in Switzerland in future. As this will affect European manufacturers in the relatively short term, transition periods are planned. Conversely, and this has already been reported, Swiss MedTech companies will now need a European Authorised Representative (Authorised Representative)from 26.05.2021. We hope that this will soon come to an end and that there will be unity again. However, the Swiss Medical Technology Association is not expecting a quick solution.
Further details and the latest news can also be found in the Newsticker of Swiss MedTech, the Swiss medical technology association.
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