Switzerland has comprehensively revised its medical devices legislation in line 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, SR 812.21),
- the Medical Devices Ordinance (MedDO, SR 812.213),
- the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219),
- the Human Research Act (HRA, SR 813.30), and
- the Ordinance on Clinical Trials with Medical Devices (CTO-MedD, SR 810.306).
Within the framework of the Agreement between Switzerland and the European Community on the mutual recognition of conformity assessments (MRA, RS 0.946.526.81), the content of the legislation is harmonised with that of the European Union (EU).
Stricter regulation
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 and have been applicable since 26 May 2021 and 26 May 2022 respectively.
Switzerland adapted its legislation in line with developments in European law. The MDR regulations were transposed into the TPA, the HRA, the MedDO and the new ClinO-MD. These regulations have been in force since 26 May 2021. The regulations of the IVDR were also transposed into the TPA, the HRA, the IvDO and the ClinO-MD, which have been in force since 26 May 2022.
Pending update of the MRA and mitigation measures
At the same time as the new MDR entered into force, Chapter 4 (Medical devices) of the MRA should have been updated. However, due to a lack of progress on institutional issues between Switzerland and the EU, the European Commission has so far refused to update this chapter. As a result, Switzerland has been considered a third country by the European Commission with regard to medical devices since May 2021, and with regard to in vitro diagnostic medical devices since May 2022 (the dates of application of the MDR and IVDR respectively). This has led to the loss of a number of previous key trading benefits between Switzerland and the EU. To take just one example, Swiss and European manufacturers are now no longer exempted from the requirement to designate an authorised representative in the territory of their contractual counterparty. At the same time, the EU has excluded Switzerland from the common market surveillance system. And Swissmedic, the Swiss market surveillance authority, has had its access to the European medical devices database revoked.
The Federal Council has adopted mitigating measures to minimise the adverse effects of the lack of an update of the MRA. 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,
- a requirement for products to be registered with Swissmedic (from July 2026, with a six-month transitional period),
- 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
After the new MDR and IVDR had come into force, it soon emerged that the transitional periods originally specified therein were not sufficiently long. In view of this, the opportunity offered by amendments to the MDR (in March 2023) and the IVDR (in June 2024) was taken to extend the transitional periods for both ordinances. Such extensions only apply under certain conditions which ensure that product safety remains guaranteed.
To maintain adequately secure supplies of medical devices and in vitro diagnostic medical devices in Switzerland and also maintain corresponding legislation which is equivalent to that of the EU, the Swiss Federal Council resolved to harmonise the relevant Swiss regulations with those of the EU, and has approved the requisite amendments to the MedDO and the IvDO, which came and come into force on 1 November 2023 and 1 January 2025 respectively.
MedDO transitional periods:
- high-risk products: until 31 December 2027
- medium- to low-risk products: until 31 December 2028.
IvDO transitional periods:
Transitional periods for products which newly require the involvement of a designated body:
- very high-risk (Class D) products: until December 2027
- high-risk (Class C) products: until December 2028
- products with increased risk (Class B) and sterile products with minimal risk (Class A): until December 2029.
Transitional periods for products for which, under present law, a certificate of conformity has been issued with the involvement of a designated body:
- All such certificates (issued between 25 May 2017 and 25 May 2022) remain valid until 31 December 2027.
MedDO and IvDO sell-off deadlines
The sell-off deadlines, which had originally been set at one year after expiration of the corresponding transitional period, have been abolished in both ordinances. This prevents the unnecessary disposal of safe medical products that are still in the supply chain.
Simplified designation requirement for certain in vitro diagnostic medical devices
As part of the mitigating measures taken by the Confederation, a transitional provision was introduced under IvDO Article 87 which was designed to reduce costs and administrative effort for the economic operators involved. This article permits a simplification of the designation requirement for in vitro diagnostic medical devices which are not intended for self-testing, and its validity was initially limited to 31 March 2025. The simplification has proved its worth, so the validity of this provision will newly be of indefinite duration from 1 January 2025 (see the report below on the analysis of mitigating actions for in vitro diagnostic medical device regulations).
Parliamentary motion
On 28 November 2022, the Federal Assembly adopted Motion 20.3211 «For greater room for manoeuvre in the procurement of medical devices to supply the Swiss population» and referred it to the Federal Council.
The motion mandates the Federal Council to revise the relevant legislation so that medical devices from regulatory systems outside of Europe can also be authorised in Switzerland.
In view of the differences between the authorisation/certification systems for medical devices outside the EU, the FOPH is currently looking at how to implement this motion without compromising patient safety. The necessary clarifications and preparatory work are under way.
The current legislation on medical devices remains in force.
Responsibilities
The FOPH prepares draft amendments to 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 Federal Department of Economic Affairs, Education and Research (EAER) and the Europe Division of the Federal Department of Foreign Affairs (FDFA).
The office responsible for the updating of the Mutual Recognition Agreement (MRA) is SECO.
Documents
All the following documents are available in French, German and Italian only
Report on the analysis of the reception measure in Art. 87 of the Ordinance on In Vitro Diagnostic Medical Devices (PDF, 2 MB, 18.11.2024)available in German only
Links
Legislation
Last modification 10.02.2025
Contact
Federal Office of Public Health FOPH
Biomedicine Division
Therapeutic Products Law Section
Schwarzenburgstrasse 157
3003
Bern
Switzerland
Tel.
+41 58 463 51 54