Medical Device Industry: Switzerland becomes a “third country”

On May 26, 2021, the Swiss Federal Council announced that Switzerland would not sign the Institutional Framework Agreement (InstA), due to substantial differences with the EU on key aspects, such as freedom of movement of persons, state aid and protection of Swiss wages.

The Institutional Agreement was supposed to regulate and facilitate Switzerland’s access to the EU single market. By the end of 2018, the EU had made it clear that, in the absence of a deal on the aforementioned Agreement, the Union would not sign new bilateral agreements with Switzerland, nor would it update existing ones.

Since Switzerland refused to finalize the Institutional Agreement, the EU decided not to update the Mutual Recognition Agreement for Medical Devices (MRA) – trade agreement regulating the access to the EU single market, promoting international harmonization of compliance standards and guaranteeing consumer protection.

The MRA between the EU and Switzerland has ceased to apply as of May 26, 2021 – date of application of the new Medical Devices Regulation (EU) 2017/745, commonly known as MDR – causing relevant consequences for the trade of medical devices.

The impact of the missing update of the MRA as of May 26, 2021

  • The European Commission has pointed out important changes for stakeholders in a document on the status of the EU-Switzerland Mutual Recognition Agreement (MRA) for Medical Devices: Swiss manufacturers are now considered as any other third country manufacturer. Particularly, new medium and high-risk medical devices must be certified by conformity assessment bodies established in the EU;Existing certificates issued under the MRA by conformity assessment bodies established in Switzerland are no longer valid in the EU;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 authorized representative was previously established in Switzerland, must designate an authorized representative established in the EU;
  • Manufacturers of medical devices on the Swiss market benefit from transitional timelines for the designation of an authorized representative in Switzerland.

Giorgia de Stefano

Regulatory Affairs Department

14.06.2021  


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References:

  • Swiss medtech (2021). Swiss medtech downgraded to «third country» status today. Retrieved on 14.06.2021 from https://www.swiss-medtech.ch/en/news/swiss-medtech-downgraded-third-country-status-today
  • The Federal Council (2021). No signing of Swiss–EU institutional agreement. Retrieved on 14.06.2021 from https://www.admin.ch/gov/en/start/documentation/media-releases.msg-id-83705.html
  • European Medicines Agency (2021). Mutual recognition agreements (MRA). Retrieved on 14.06.2021 from https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/mutual-recognition
  • European Commission (2021). Notice to stakeholders: status of the EU-Switzerland Mutual Recognition Agreement (MRA) for Medical Devices . Retrieved on 14.06.2021 from https://ec.europa.eu/health/sites/default/files/md_dialogue/docs/mdcg_eu-switzerland_mra_en.pdf
  • MDlaw (2021). Switzerland & MDR DoA: Update. Retrieved on 14.06.2021 from https://mdlaw.eu/mdr/switzerland-mdr-doa-update/