link Collection
Find the most important links about medtech regulations from the authorities here.
Links of national authorities
Swissmedic
Swissmedic is the Swiss Regulatory and Supervisory Authority for Medicinal Products and Medical Devices. Swissmedic's website provides information (incl. links) on relevant legal foundations and competent authorities. It also contains information regarding other issues such as the authorisation of medical devices, clinical trials, as well as market control and monitoring.
Federal Office of Public Health
Switzerland has had national regulations on medical devices in place since 1996. The field of medical technology is regulated by the Federal Law on Medicinal Products and Medical Devices (Therapeutic Products Act, HMG) and its associated ordinances.
State Secretariat for Economic Affairs – SECO
Switzerland is integrated into European market surveillance and the European internal market for medical devices via the Switzerland-EU Mutual Recognition Agreement (MRA, AS 2007 713). Switzerland, represented by SECO, is negotiating the adaptation of the MRA with the EU (Section 4) in order to establish mutual obligations according to international law.
Links of the European Commission
In the European Union (EU), Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-vitro Diagnostic Medical Devices (IVDR) entered into force on 26 May 2017. The dates of application were 26 May 2021 (MDR) and 26 May 2022 (IVDR). Both EU regulations are directly applicable in the member states, and are binding.
