The Federal Council defines guidelines for expanding the supply of medical devices
Bern, 30.04.2025 — At its meeting on 30 April 2025, the Federal Council noted the ongoing efforts to implement Motion 20.3211, which aims to open the possibility for medical devices from non-European regulatory systems to be placed on the Swiss market. In order to ensure adequate supplies of medical devices and to guarantee patient safety, the Federal Council defined guidelines and will assign responsibility for controls to private bodies.
In November 2022, the National Council referred to the Federal Council the motion (20.3211) brought by Damian Müller, a member of the Council of States, calling for measures to enable medical devices from non-European regulatory systems to be placed on the market in Switzerland. The aim of this motion is to expand sources of medical device supplies beyond the European Union (EU), including in particular devices authorised by the US Food and Drug Administration (FDA).
Patient safety
Currently, only devices with a declaration of conformity issued in accordance with Swiss or EU legislation are recognised in Switzerland. As medical device regulations are not harmonised at the global level, the process of opening-up to other markets needs to be approached cautiously, in order to maintain the safety of patients and device users.
From 2017, following various incidents and scandals involving medical devices – for example, those associated with defective breast implants and hip replacements – the EU adopted a more rigorous regulatory framework so as to ensure a high level of protection of heath and patients. In order to ensure equivalent safety levels, and in accordance with the agreement between the Swiss Confederation and the European Community on mutual recognition in relation to conformity assessment (MRA), Switzerland adapted its legislation to that of the EU. These new regulations have been in force in Switzerland since May 2021 for medical devices, and since May 2022 for in vitro diagnostic medical devices.
The parliamentary motion calls for measures to permit medical devices from non-European regulatory systems to be placed on the market in Switzerland. To prepare for implementation, a working group has been established, comprising representatives of the Federal Office of Public Health, Swissmedic, the State Secretariat for Economic Affairs, and the Europe Division of the State Secretariat of the Federal Department of Foreign Affairs. The working group identified differences between the regulatory systems in Switzerland and the US, which need to be taken into account.
It proposed to the Federal Council conditions for the introduction on the Swiss market of devices authorised by the FDA. In particular, these involve compliance with Swiss legal requirements concerning data protection or a quality management system. Also envisaged is the definition of a post-marketing surveillance plan and the possibility of requiring clinical evidence.
Controls by private bodies
An impartial assessment and effective controls are necessary to ensure the safety of the medical devices concerned. The Federal Council intends to assign responsibility for reviewing the conditions for devices already authorised by the FDA in the US to private bodies. These bodies will review the relevant conditions under a simplified conformity assessment procedure, taking into account elements already performed by the FDA.
Next steps
The Federal Council has therefore requested the Federal Department of Home Affairs (FDHA), in collaboration with the Federal Department of Economic Affairs, Education and Research (EAER) and the Federal Department of Foreign Affairs (FDFA), to explore this approach in more detail.
Medical devices
Medical devices comprise a wide variety of products used for medical, therapeutic or diagnostic purposes. They include, in particular, implants such as hip replacements, cardiac pacemakers, complex equipment such as scanners, or more simple devices such as spectacles. They also include diagnostic laboratory tests known as in vitro diagnostic medical devices.
Unlike medicinal products, which undergo official authorisation, medical devices are subject to a conformity assessment procedure. Depending on the risk class, an independent body is responsible for assessing the compliance of devices with legal and technical requirements. This system is designed to guarantee access to innovative products, while at the same time ensuring that medical devices are safe both for the people who work with these products and for patients.
Further information: Medical devices legislation