ReguLation
Relevant for medical technology is the Swiss law on medical devices, namely the Federal Law on Medicinal Products and Medical Devices (Law on Therapeutic Products, HMG) including the respective regulations. Furthermore, there is legislation affecting innovation, research, transparency, quality, tariffs and trade, among other things. As a strong export industry, the Swiss medical technology industry relies on as smooth as possible access to the important export markets and on competitive conditions.
Medical Device Regulation in Switzerland
Switzerland has had a national medical device regulation since 1996.
The partial revision of the Law on Therapeutic Products (HMG, SR 812.21) and the Human Research Act (HFG, SR 810.30) established the necessary legal basis in order to adapt the implementing legislation to the new EU Medical Device Regulation.
The Federal Council therefore published the following legislation on 1 July 2020:
- Revised Medical Devices Ordinance (MepV, SR 812.213, entry into force 26 May 2021);
- Ordinance on Clinical Trials with Medical Devices (KlinV-Mep, SR 812.213.3 (German), entry into force 26 May 2021);
- Amended Medical Devices Ordinance (AS 2020 2975, entry into force 1 August 2020). Upon substantiated request, a medical device can be placed on the market without a conformity assessment or without fulfilment of the language requirements pursuant to Art. 7 (2).
The website of the Swiss Agency for Therapeutic Products (Swissmedic) provides comprehensive and current information including related links to the relevant legal framework and competent authorities. In addition, there are also interesting facts on further areas, such as the marketing authorisation of medical devices, clinical trials, and market control and monitoring.
Switzerland is also involved in European market surveillance and the European single market for medical devices via the Swiss-EU Agreement on the Mutual Recognition of Conformity Assessments (Mutual Recognition Agreement, MRA, AS 2007 713). To maintain mutual obligations under international law, Switzerland, under the leadership of the State Secretariat for Economic Affairs (SECO), is currently negotiating the adjustment of the MRA (chapter 4) with the EU.
In March 2016, the Parliament set out new provisions on non-cash benefits by introducing 2 new articles on integrity (Art. 55 HMG) and transparency (Art. 56 HMG) in the field of therapeutic products. The new Ordinance on the Integrity and Transparency in the field of Therapeutic Products (VITH, SR 812.214.31, in German only) entered into force on 1 January 2020. At present, only the transparency provisions (Art. 56 HMG and Art. 10 et seq. VITH) apply to medical devices.
Medical Device Regulation in Europe
In the European Union (EU) the following new regulations came into effect on 26 May 2017 with graduated transitional periods:
- Regulation (EU) 2017/745 on Medical Devices (MDR)
- Regulation (EU) 2017/746 on In-vitro Diagnostic Medical Devices (IVDR)
Date of application is 26 May 2021 (MDR) and 26 May 2022 (IVDR). The two EU regulations are directly applicable in the member states and are binding.
