Swiss domestic medtech manufacturers reluctantly accept Switzerland’s new status as a third country to the EU, but the Swiss industry is anxious that new national regulations do not impose higher hurdles than the EU MDR. At present, there is a risk of that happening.
Swiss medtech manufacturers appear to have taken a pragmatic view of the country’s newfound status as a third country to the EU, in the months since the EU Medical Device Regulation took effect. In the absence of the mutual recognition agreement (MRA) with the EU, the MDR does not apply directly in Switzerland, as the medical device directives did, so Switzerland enacted its own national Medical Device Ordinance (MedDO/MepV).
The revised Swiss medical device legislation was put in place to maintain Switzerland’s orientation towards both the MDR and the future IVD Regulation, regarding product quality, safety and efficacy. At some point in the future, a Swiss referendum might lead to a situation where mutual recognition and free market access are once again in place for both parties.
