EU-Switzerland: MRA for Medical Devices no longer valid

Recommendation

7/8 May 2024

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The Mutual Recognition Agreement (MRA) between the EU and Switzerland has so far allowed medical device manufacturers from the EU and Switzerland to access the respective markets based on equivalent regulations until now. At the end of May, the EU Commission then announced that these mutual recognition procedures are no longer valid. This is related to the new Medical Devices Regulation (EU) 2017/745 that has come into force on 26 May 2021. The EU had made it clear during the negotiations that without an agreement on the institutional framework agreement between the EU and Switzerland, there could also be no update of the Mutual Recognition Agreement (MRA), including the chapter on medical devices. Now it has come to this.

On 30 March, the EU proposed a limited modification of the MRA to Switzerland, including a transitional period, but no agreement was reached. As a result, not even existing Swiss certificates of conformity or existing certificates issued in the EU will remain valid.

Now massive problems are expected. According to the German press release, Switzerland exports 46 percent of its medical devices to the EU and imports 54 percent from the EU. In comparison, the EU imports 10 per cent of medical devices from Switzerland and exports only 5 per cent of medical devices to Switzerland. Now Switzerland is effectively a third country here. This is also clearly expressed in the corresponding Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for Medical Devices. Further consequences include (quote):

• "For all new devices, Swiss manufacturers will be treated as any other third country manufacturer intending to place their devices on the EU market. In particular, new Swiss medium and high-risk devices must be certified by conformity assessment bodies established within the EU.
• Existing certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognised as valid in the EU.
• For existing certificates issued under the MRA by conformity assessment bodies established in the EU, Swiss manufacturers and third country manufacturers whose authorised representative was previously established in Switzerland, must designate an authorised representative established in the EU.

On 19 May 2021, the Swiss Federal Council adopted an amendment to the Swiss Ordinance on Medical Devices establishing conditions for trade of medical devices covered by EU issued certificates on the Swiss market. This includes the recognition of existing certificates issued under the MRA by conformity assessment bodies established in the EU and transitional timelines for the designation of a representative in Switzerland for EU/EEA manufacturers of medical devices."

Furthermore, it should be noted that Swiss authorities do not have access to EUDAMED (which is the IT system developed by the European Commission to implement the MDR Regulation (EU) 2017/745 on medical devices and the IVDR Regulation (EU) 2017/746 on in vitro diagnostic medical devices). They are also not (anymore) part of the working groups on joint surveillance of new medical devices.