Risk management, Essential Safety and Performance Requirements (MDR-Annex I) and clinical evaluation are affected by the modifications of the Swiss MepV.
The Swiss Federal Council decided at the end of September to amend the Swiss Medical Devices Ordinance (MePV) to improve the safety of devices without a medical purpose. Switzerland has adapted its MepV for these products to the EU requirements, taking into account the new transition periods. The necessary amendments to the MepV have been adopted and will enter into force on 1 November 2023.
The implementing regulations tighten the requirements for product groups without a medical purpose that are comparable to medical devices in their functionality and risk profile. These products fall within the scope of the MepV (Art. 1 para. 1 let. a). They are mainly used in cosmetics, cosmetic surgery, body forming and occasionally in interventional psychiatry and ophthalmic optics. Annex 1 of the MepV lists the product groups without a medical purpose that must in future comply with the common specifications in accordance with the EU Commission's Implementing Regulation (EU) 2022/2346 of 1 December 2022. This concerns in particular the application of risk management according to the general safety and performance requirements of annex I of the EU MDR and the clinical evaluation.
If you have any questions regarding Swiss regulations or CE documentation for Switzerland, please contact BEO BERLIN.