Keeping a finger on the pulse of Swiss medical device regulation: new agreement signed between the EU and Switzerland
Swiss medical device regulation is largely consistent with the requirements of the EU MDR, with the aim of achieving a comparable level of quality and safety. However, since the Mutual Recognition Agreement (MRA) ceased to apply in 2021, the EU is considered a third country from Switzerland’s perspective. For EU manufacturers, this results in additional requirements when placing medical devices and in vitro diagnostic (IVD) devices on the market in Switzerland, such as the appointment of a Swiss authorised representative and separate registration and reporting obligations.
Although EU CE certificates continue to be recognised, Switzerland-specific economic operators and national processes are required, as automatic mutual recognition no longer applies. In practice, this MRA gap leads to additional administrative hurdles for manufacturers.
Against this background, the signing on 2 March 2026 of a comprehensive package of agreements between the EU and Switzerland is of great significance. The package includes, amongst other things, a protocol amending the existing MRA. For medical devices and IVDs, the key point is the planned restoration and modernisation of the mutual recognition of certifications and conformity assessments. In future, products certified in accordance with EU regulations should be accepted in both markets without having to undergo duplicate testing or authorisation procedures. The underlying safety and quality standards will remain high and comparable; this is to be ensured, amongst other things, by the ‘equivalence method’, which must be enshrined in Swiss law to ensure continuous alignment with European law. Industry associations on both sides have welcomed these new efforts.
However, the signing of the agreement does not have immediate legal effect. The next step requires ratification on both sides. In the EU, the agreement must be approved by the European Parliament and the Member States. In Switzerland, it will go through the parliamentary process and is expected to be subject to an optional referendum. It is not expected to enter into force before 2028. Only then could key simplifications take effect, such as the abolition of the role of the Swiss authorised representative (CH-REP) following the corresponding amendment of the Medical Devices Ordinance and the In Vitro Diagnostics Ordinance (MepV, IvDV).
Current requirements until the MRA update comes into force
Until the ratification and formal entry into force of the updated MRA, the existing Swiss special regulations will continue to apply unchanged. This continues to impose specific obligations on German and other EU manufacturers:
Swiss authorised representative (CH-REP)
Foreign manufacturers must continue to appoint a Swiss authorised representative in order to place products on the market in Switzerland. This obligation applies to all medical devices and IVDs, regardless of their risk class, including so-called legacy products with older CE certificates (MepV Art. 51(1)). The CH-REP acts as the official point of contact for Swissmedic and shares liability with the manufacturer. Their responsibilities include, amongst other things, extended obligations in the area of product safety and ensuring the availability of technical documentation.
Importer and distributor
For medical devices and IVDs from the EU, an importer based in Switzerland is generally required, unless the manufacturer supplies Swiss healthcare facilities directly. The importer assumes obligations comparable to those of an EU importer under the MDR or IVDR, and must be named on the product or its packaging. Distributors are subject to corresponding due diligence obligations, for example regarding storage and transport. It is therefore essential for manufacturers to have a reliable distribution partner in Switzerland who works closely with the CH-REP.
Product registration (swissdamed)
Since 2025, Switzerland has been operating its own medical device register, ‘swissdamed’, as the national counterpart to EUDAMED. Foreign manufacturers must register themselves and their products there. Currently, swissdamed covers the registration of economic operators as well as the UDI product module.
From 1 July 2026, the registration of medical devices, systems and treatment units will be mandatory, with a transition period until 31 December 2026. For manufacturers, this means operating both EUDAMED and swissdamed in parallel.
CE marking, documentation and vigilance
The CE marking continues to be recognised in Switzerland; a separate national authorisation is not required. However, all relevant economic operators – manufacturers, CH-REPs and importers – must be named, with their names and addresses, on the product or its packaging. Instructions for use and labelling must be provided in the official Swiss languages where applicable.
In the area of vigilance, Swissmedic acts as an independent market surveillance authority. Serious incidents in Switzerland must still be reported directly to Swissmedic; there is no automatic forwarding of EU reports. The CH-REP plays a central role in this regard, particularly in initiating and submitting Field Safety Corrective Actions and trend reports.
Conclusion
The political agreement of 2026 opens up a realistic prospect for renewed regulatory convergence between the EU and Switzerland. In the short term, however, manufacturers must continue to operate on two tracks and ensure access to the Swiss market in accordance with existing national requirements. Close cooperation with CH-REP, importers and industry associations, as well as early strategic preparation for the future MRA update, therefore remain crucial.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
