In a New Statesman article on the Swiss government's abandonment of a [further] EU framework treaty with the EU, some possible negative consequences are mentioned:

even if the collapse of this framework doesn’t mean the existing accords are all torn up, it already has consequences for the short term. The Commission must decide soon whether medical equipment produced in Switzerland can be given equivalence. If not, Swiss companies will have to move production into the EU. Decisions on university funding will follow, as well as on electricity. So while existing accords will likely remain, it’s now unlikely there will be new ones. “Without this agreement, this modernisation of our relationship will not be possible and our bilateral agreements will inevitably age," the European Commission said following Bern’s announcement.

The question may be a bit premature, but have there been any "retaliatory"/negative consequences insofar for Switzerland rejecting the framework treaty with the EU, along the lines of those mentioned in that article?

1 Answer 1


Yes; May 26th - the date on which the Swiss Federal Council declined to sign the Institutional Framework Agreement (IFA) - was also the deadline for the renewal of the mutual recognition agreement (MRA) between the EU and Switzerland on medical devices. This came about due to the Medical Devices Regulation (EU) 2017/745 coming into full force on that date; the unaltered MRA refers to the old Medical Devices Directives which are no longer in force.

The EU published a notice to stakeholders upon the expiry of the agreement, which notes the following consequences of the MRA not being updated:

The following consequences as of 26 May 2021 should therefore be noted by stakeholders:

  • 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.

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