Oct 13, 2020

On September 27, 2020, the Swiss held one of their many referendums. Due to the COVID-19 pandemic the referendum in May 2020 had been postponed. This resulted in a total of five issues they were asked their opinion about, so the Swiss had to do a bit of homework before spending their Sunday on casting their vote. Subjects covered included a vote on whether to limit immigration for EU citizens, which also had implications for the Medical Devices Regulation’s (MDR) date of application in Switzerland.

Immigration, InstA and MDR

The question regarding immigration was seen as the most important item of this session. Switzerland is not part of the EU but is bound to the union through a series of agreements. There is, for example, a Mutual Recognition Agreement (MRA) covering medical devices in order to enable these devices move freely between the EU and Swiss markets.

There are over 120 MRAs linked to a wider framework agreement. In 2014 Switzerland and the EU started to negotiate a new Institutional Framework Agreement (‘InstA’), which resulted in a proposal in 2018. InstA is sometimes labelled as “EEA light,” as it contains many of the items currently included in the EEA framework, but without a central controlling body. However, at the end of 2018 the Swiss rejected this proposal in a public consultation. The main reason had to do with immigration by EU citizens. That rejection had been fueled by the right-wing Swiss political party SVP, which claimed that these immigrants were taking away jobs from the Swiss and benefitting from Swiss social security. With InstA rejected, it is not possible to sign new MRAs. This means the immigration issue is about much more than allowing free movement of people; Swiss stock exchanges have no longer direct access to EU markets, and the medical device industry now sees the consequences of this vote with the MDR not being covered by a signed MRA.

Next steps, and effects on MDR, IVDR

Now that the Swiss people have expressed a clear opinion on immigration, the road is clear to rethink the implementation of InstA. This will require at least one new referendum, which will take time. It is therefore expected that InstA will be signed no earlier than in Q2 of 2022, but possibly later. This also implies that the MRA for the MDR will not be signed before the Regulation’s date of application in May 2021. It is also questionable whether the MRA for the In-vitro Diagnostic Medical Devices Regulation (IVDR) will be signed on its date of application in May 2022. This means that for medical devices and IVDs, Switzerland will become a third country, at least for some time. This means that for each market importers and Authorized Representatives must be appointed for any cross-border traffic. Emergo recommends starting appointing these economic operators now to avoid congestion around the MDR date of application.

Ronald Boumans is Senior Consultant, Regulatory Affairs at Emergo by UL.

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  • Ronald Boumans

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