Switzerland has comprehensively revised its medical devices legislation in close correlation with the EU Regulations on medical devices (MDR and IVDR), thereby increasing the safety and quality of medical devices.
Medical devices in Switzerland
Medical devices are regulated in Switzerland by the following acts and ordinances:
- the Therapeutic Products Act (TPA),
- the Medical Devices Ordinance (MedDO),
- the Ordinance on In Vitro Diagnostic Medical Devices (IvDO),
- the Human Research Act (HRA), and
- the Ordinance on Clinical Trials with Medical Devices (CTO-MedD).
The content of the legislation is harmonised with that of the European Union (EU) and should therefore facilitate commerce and trade in this sector. This was also specified in the agreement between Switzerland and the EU on the mutual recognition of conformity assessments (MRA).
In recent years, the EU has made requirements for medical devices stricter to increase the quality and safety of these products. The EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) entered into force on 26 May 2017.
Likewise, Switzerland has revised its legislation based on that of the EU. The provisions of the MDR have been transferred to the Therapeutic Products Act, the Human Research Act, the Medical Devices Ordinance and the new Ordinance on Clinical Trials with Medical Devices. These provisions entered into force on 26 May 2021, the date of application of the EU regulations. In addition to the revisions in the TPA and HRA, the provisions of the IVDR were also transferred to the Ordinance on In Vitro Diagnostic Medical Devices and CTO-MedD, which have been in force since 26 May 2022.
Pending update of the MRA
Due to a lack of progress on institutional issues between Switzerland and the EU, the European Commission has to date rejected any update to Chapter 4 (Medical devices) of the MRA. Consequently, Switzerland has been classed by the EU as a third country since 26 May 2021 in this area and since 26 May 2022 in relation to in vitro diagnostic medical devices (dates of entry into force of both new acts in Switzerland and applicability in the EU). This means that significantly eased trading conditions no longer apply between Switzerland and the EU, for example the mutual dispensing with the need for manufacturers to mandate an authorised representative in the other respective country.
At the same time, the EU has excluded Switzerland from the European market surveillance system. For example, Swissmedic, the Swiss market surveillance authority, has had its access to the new European database for medical devices revoked.
Mitigating measures by the Federal Council
To alleviate the effects of a lack of update to the MRA, the Federal Council adopted mitigating measures. These are designed to safeguard the supply of safe medical devices in Switzerland and ensure market surveillance. They include, for example:
- unilateral recognition of medical devices with an EU conformity assessment (CE marking),
- mandatory registration with Swissmedic for economic operators,
- reporting serious incidents to Swissmedic.
Further information on the obligations of economic operators in Switzerland can be found on the Swissmedic website: Medical devices (swissmedic.ch).
Security of supply
In June 2022, the Federal Council examined whether further measures were required to safeguard the supply of safe and correctly performing medical devices in Switzerland, should an updated MRA be delayed for a longer period. This included drawing up Swiss medical devices regulations. The basis for this was an analysis of various forms of regulations, developed by the Federal Department of Home Affairs (FDHA) together with the Federal Department of Economic Affairs, Education and Research (EAER) and the Federal Department of Foreign Affairs (FDFA). The Federal Council concluded that the mitigating measures taken had achieved their objective to date and therefore saw no urgent need to revise the relevant legislation.
Modifications in the EU
In January 2023, the European Commission proposed measures to address the risk of medical device shortages as a result of a lack of capacity at conformity assessment bodies in the EU (Public health: medical devices (europa.eu)).
These measures are yet to be adopted by the European Parliament and the European Council.
The objective of the Federal Council continues to be to ensure the supply of medical devices in Switzerland and to maintain equivalence with the European regulations on medical devices.
If the proposal of the European Commission is adopted by the European Council, Switzerland will adapt its regulations on medical devices accordingly in autumn 2023, subject to adoption by the Federal Council.
The motion «For greater room for manoeuvre in the procurement of medical devices to supply the Swiss population» by member of the Council of States Damian Müller (20.3211) was approved by both Councils and referred to the Federal Council on 28 November 2022.
The motion mandates the Federal Council to revise the legislation so that medical devices from regulatory systems outside of Europe can also be authorised in Switzerland.
The approval/certification systems for medical devices outside the EU differ greatly from the certification system currently in force in the EU and Switzerland.
The Federal Council is currently examining how this motion can be implemented. It must continue to ensure patient safety. In addition, further clarifications and preparatory work are required before the actual legislative process can start.
The current legislation on medical devices remains in force.
The FOPH adapts Swiss medical devices legislation on behalf of the FDHA. This is done in close collaboration with Swissmedic, the State Secretariat for Economic Affairs (SECO), the EAER and the Europe Division of the FDFA.
The office responsible for the updating of the Mutual Recognition Agreement (MRA) is SECO.
All documents are available in French, German and Italian only
Dispatch of 30 November 2018 on the amendment to the Therapeutic Products Act (new regulations on medical devices) (PDF, 799 kB, 14.05.2021)
Explanatory report on the total revision of the Ordinance on Medical Devices and the Ordinance on Clinical Trials with Medical Devices (new medical devices regulations) (PDF, 1 MB, 06.10.2022)
Explanatory report on the new ordinance on in vitro diagnostics and amendments to the Ordinance on Clinical Trials for Medical Devices (ClinO-MD) (PDF, 1 MB, 14.05.2021)
Consultation report on the amendment to the Therapeutic Products Act (new regulations on medical devices) and the Federal Act on Technical Barriers to Trade (PDF, 497 kB, 14.05.2021)
Consultation documents: Total revision of the Medical Devices Ordinance and new Ordinance on Clinical Trials with Medical Devices (including consultation report)
Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices 20.06.1999
Last modification 03.02.2023
Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
Tel. +41 58 463 51 54