On 26 May 2021, the mutual recognition agreement between the EU and Switzerland that included medical devices ceased to apply. Among the practical consequences of this step was that Swiss manufacturers were no longer able to claim mutual recognition of their medical devices on the EU market. Manufacturers of medical devices of Swiss origin were, thereafter, required to fulfil the same obligations as other third country manufacturers before placing their devices on the EU market.
Since that time, there have been ongoing attempts to revive related bilateral agreements. The recent Council Decision on the signing of a broad package of agreements between the EU and Switzerland, which was the subject of a communication by the Council that was published today, 24 February 2026, may result in reestablishment of the mutual recognition process.
Negotiation of agreements and protocols, include an Amending Protocol to the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment and an Institutional protocol to the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment, which would reintroduce mutual recognition of medical devices, were concluded on 20 December 2024.
Signature of the agreements and protocols by the EU and Switzerland is planned to take place in March 2026. However, the package will come into practical effect only after Switzerland has completed its national procedures necessary for the entry into force of the package in the country. This includes adoption of the package by the Swiss Parliament and, in the event of a referendum, approval by Swiss voters.