Medical devices

Bern, 30.4.2025 – The Swiss population relies on a good supply of medical devices including implants, products for injection, infusion, transfusion and dialysis, dental products, laboratory diagnostics and in vitro diagnostics. The Federal Council now wants to lay the foundations for bringing medical devices available on the US market to the Swiss market, provided they meet our patient safety requirements.

Medical devices include implants such as pacemakers and artificial hip joints, imaging equipment such as X-ray machines, and diagnostic tools for examining samples taken from the human body. All these products are key to healthcare provision, which means their safety is crucial.

Unlike medicinal products, which require official approval, medical devices in Switzerland and the European Union are tested for safety through conformity assessments or certifications before they can be placed on the market.

International framework: EU and non-European systems

In response to a scandal involving defective implants, in 2017 the EU tightened its requirements for medical devices. To increase safety in this country too, Switzerland has aligned its market access legislation with that of the EU. The same rules apply, which means that products with a European conformity mark (CE mark) may also be placed on the market in Switzerland.

Until 2021, a Mutual Recognition Agreement (MRA) between the EU and Switzerland guaranteed mutual market access. However, the EU has not updated the MRA since then because it is linking this step to the clarification of institutional issues between Switzerland and the EU. Switzerland is therefore currently treated as a third country, but unilaterally recognises EU conformity assessments.

To broaden access to the Swiss market, Parliament has instructed the Federal Council to amend legislation so that medical devices from non-European regulatory systems are taken into account in Swiss legislation. Implementation is currently focused on medical devices approved by the US Food and Drug Administration (FDA). The US approval system is comparable in part to Swiss and European regulations. However, there are some differences.

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.