Swiss Federal Council approves tightening of safety and traceability rules for medical devices
The Swiss Federal Council recently approved significant amendments to national legislation on medical devices, with the aim of strengthening patient protection and aligning the Swiss legal framework with European Union requirements, despite Switzerland not currently being party to the updated Mutual Recognition Agreement (MRA) with the EU.
The measures adopted aim to address regulatory gaps that have existed since the entry into force of the European Medical Devices Regulation (MDR), promoting greater transparency, traceability, and post-market surveillance.
Main changes approved:
Strengthening of market surveillance requirements, including stricter reporting requirements for economic operators;
Introduction of more demanding traceability mechanisms, in particular through the increased use of Unique Device Identifiers (UDI);
Additional obligations for importers and distributors of medical devices in Switzerland;
Partial alignment with the requirements of the European MDR, with a direct impact on authorization and maintenance procedures in the Swiss market;
New obligations for authorized representatives in Switzerland, particularly with regard to technical documentation and incident response.
These changes will be implemented gradually, with deadlines set for companies to adapt to the new requirements. The main objective is to maintain a high standard of safety for users of medical devices in Switzerland.
