Revision of Swiss medical devices legislation

Following a number of incidents, the EU has introduced stricter control mechanisms throughout Europe for the placing on the market and control of medical devices. Switzerland has also revised its medical devices legislation based on two new EU Regulations.

Existing medical devices regulation in Switzerland

The Medical Devices Ordinance (MedDO) has been in force since 1 January 2002. The European directives on classical medical devices, active implants and in vitro diagnostic medical devices were incorporated into Swiss law.

Revisions were made on 1 April 2010 as part of the Therapeutic Products Ordinance Package III. As a result, Swiss law was harmonised with the EU's revised medical devices directives, which have been in force since 21 March 2010. Furthermore, the MedDO was revised with effect from 15 April 2015 to bring the requirements for conformity assessment bodies into line with the EU's tougher requirements.

EU developments

Following various incidents and scandals connected with medical devices (including leaky silicone breast implants and defective hip prostheses), doubts were raised about the surveillance system for medical devices in the EU. In order to improve patient safety and the performance of medical devices, on 5 April 2017 the EU adopted the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). Both regulations entered into force on 26 May 2017. The dates of application were 26 May 2021 for the MDR and 26 May 2022 for the IVDR.

Amendments in Switzerland

The alignment of Swiss medical devices legislation to the two EU Regulations MDR and IVDR also aimed to improve the safety and performance of medical devices and thereby increase the protection of patients. The adaptation of Switzerland's medical devices legislation took place gradually and in coordination with the transition periods in the EU. As a result, equality before the law is guaranteed between Switzerland and the EU.

Focus on patient safety

The revision has imposed significantly tighter requirements for all stakeholders. Thus, for example, manufacturers have to prove the usefulness and effectiveness of high-risk devices in much greater detail by means of clinical trials. Stricter criteria for the approval and monitoring of clinical trials and performance testing have been introduced. In addition, the clear identification of all devices will be required in order to enable their full traceability. At the same time, the responsibilities and requirements of the competent authorities and conformity assessment bodies organised by the private sector will become substantially more far-reaching.

Situation as of May 2022

In the first stage, the initial revision of MedDO was completed on 25 October 2017. This has ensured that Swiss conformity assessment bodies can be recruited for the designation process and, provided the requirements are met, issue certificates of conformity on behalf of the manufacturer for medical devices in accordance with the new medical devices legislation.
According to the new legislation, manufacturers can carry out the conformity assessment procedure. The revision has also regulated the cooperation between the EU and Switzerland in relation to market surveillance.
In the second stage, on 22 March 2019 the Swiss Parliament adopted the revision of the Therapeutic Products Act and the Human Research Act as the basis for further ordinance adaptations.
This was followed by the total revision of the MedDO and a new ordinance on clinical trials for medical devices (ClinO-MD). The transition of the EU MDR into Swiss medical devices legislation was complete when these provisions entered into force on 26 May 2021.
In the third and final stage, the provisions of the EU IVDR were transferred to a new Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO), and individual specific rulings connected with in vitro diagnostic medical devices (IVDs) were adapted in the ClinO-MD. These provisions entered into force on 26 May 2022, thereby completing the revision of Swiss medical devices legislation.

Non-updating of the Mutual Recognition Agreement (MRA)

The alignment of the Swiss medical devices legislation with the new EU Regulations MDR and IVDR also requires the updating of Chapter 4 Medical Devices in Annex 1 of the agreement between Switzerland and the EU on the mutual recognition of conformity assessments (MRA, SR 0.946.526.81).
In order to maintain ease of market access and ensure joint enforcement with the EU, the updating for medical devices should have been completed by 26 May 2021 and, for in vitro diagnostic medical devices, by 26 May 2022. However, the EU is making the updating of the MRA dependent on the resolution of institutional issues (see Press release by the Federal Council dated 26.5.2021).
Consequently, Switzerland has been classed by the EU as a third country since 26 May 2021 in relation to medical devices and since 26 May 2022 in relation to in vitro diagnostic medical devices. 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.
In order to mitigate the consequences of the non-updating of the MRA, on 19 May 2021 the Federal Council adopted corresponding measures for medical devices, which entered into force at the same time as the MedDO, on 26 May 2021. On 4 May 2022, it also adopted mitigating measures for in vitro diagnostic medical devices, which entered into force at the same time as the Ordinance on In Vitro Diagnostic Medical Devices (IvDO), on 26 May 2022.
Some of these measures are designed to improve conditions for economic operators. For example transition periods will be granted (graded according to the risk classes of the medical devices and in vitro diagnostic medical devices) for mandating a Swiss authorised representative for EU manufacturers, and the labelling requirements for medical devices will be eased. Furthermore, the marketability of medical devices with an EU conformity assessment (CE marking) will continue to be recognised unilaterally.
Other mitigating measures concern the mandatory registration of Swiss economic operators and the obligations for reporting to Swissmedic. These mitigating measures are designed to ensure that the orderly supply of safe and correctly performing medical devices is maintained in Switzerland.

Responsibilities

The FOPH adapts 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.

Further information

New regulations for clinical trials of medical devices

Switzerland is adapting its medical devices regulations to the new EU rules. This will have implications for the legislation on human research.

Last modification 08.07.2022

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Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
Schwarzenburgstrasse 157
3003 Bern
Switzerland
Tel. +41 58 463 51 54
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