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SWIXIT – Effects on the current status of the EU-Switzerland mutual recognition agreement (MRA) for medical devices markets

Until now, Switzerland has been participating in the European Union internal market for medical devices through a specific chapter of the EU-Switzerland Mutual Recognition Agreement (MRA). The medical devices chapter of the MRA has provided for recognition of conformity assessment certificates between the European Union and Switzerland based on equivalent regulations. This has facilitated seamless trade of medical devices between the parties. EU Medical Devices Regulation (EU MDR) is not included in the current version of the medical devices chapter of the MRA.

Updates, including elements from EU MDR, was not approved for mutual recognition agreement on the Date of Application following consequences listed below as of 26 May 2021.

These should be noted by Swiss medical device manufacturers and legal manufacturer with Swiss Notified body or Swiss-based Authorized Representative:

  • 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 notified 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 notified 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.

It is also noteworthy that the medical devices chapter of the EU-Switzerland MRA also covers trade of In vitro diagnostic (IVD) medical devices, based on the Directive 98/79/EC and the corresponding Swiss legislation. This part of the chapter continues to apply until the date of application of Regulation (EU) 2017/746 on IVD medical devices.

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