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 are fully 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
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 (dates of application of the MDR and IVDR, respectively). In consequence, significantly eased trading conditions, such as the mutual possibility for European and Swiss manufacturers not to appoint an authorised representative on the territory of the other contracting party, no longer apply between Switzerland and the EU. At the same time, the EU has excluded Switzerland from the common market surveillance system. Swissmedic, the Swiss market surveillance authority, has had its access to the European medical devices database 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
The new regulation on medical devices (MDR and MedDO) was accompanied by a transition period until 26 May 2024. However, the bodies in the EU responsible for assessing the conformity of medical devices do not have sufficient capacity to certify all devices by that date. For this reason, the European Parliament and the Council urgently adopted the Regulation (EU) 2023/607 on 15 March 2023 to extend the transition periods under certain conditions.
In order to safeguard the security of supply of medical devices in Switzerland, the Federal Council decided to align the Swiss regulations with those of the EU. The necessary modifications in the MedDO and IvDO were therefore adopted and will come into effect on 1 November 2023. The transition period in the MedDO is extended to 31 December 2027 for high-risk devices, and to 31 December 2028 for devices with a medium or low risk. This extension is subject to certain conditions to ensure that only safe medical devices benefit from the extra time.
In addition, the sell-off rule, which was initially stipulated at one year after the end of the transition period, has been abolished in both ordinances. This measure avoids the unnecessary disposal of safe medical devices in the supply chain.
Products without an intended medical purpose
On 1 December 2022, the European Commission adopted Implementing Regulations (EU) 2022/2346 and (EU) 2022/2347, reinforcing the requirements for groups of products without an intended medical purpose. These products, which are mainly cosmetic products, but whose risk profile is similar to that of medical devices, feature in Annex 1 to the MedDO. In order to enhance the safety of these products in Switzerland, the Federal Council decided to align the Swiss regulation with that of the EU. These products are subject to the regulations on medical devices, taking into account the transition periods applicable in the EU.
Parliamentary motion
On 28 November 2022, the Federal Assembly adopted the 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 legislation so that medical devices from regulatory systems outside of Europe can also be authorised in Switzerland.
Given 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 Federal Department of Home Affairs (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 following documents are available in French, German and Italian only
Links
Legislation
Last modification 29.09.2023
Contact
Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
Schwarzenburgstrasse 157
3003
Bern
Switzerland
Tel.
+41 58 463 51 54