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Following the Termination of Negotiations Between the EU and Switzerland on the Institutional Framework Agreement, the Swiss Medical Technology Industry Has Lost Its Barrier-Free Access to the EU Internal Market

On the night of 26 May 2021, the Swiss Federal Council announced that it had terminated negotiations with the EU on the Institutional Framework Agreement. For the medical devices sector, this has implications for trade between the EU and Switzerland, which will now be “downgraded” and treated as a third country.

The Mutual Recognition Agreement (MRA) has long existed as one of the most important agreements between the EU and Switzerland, facilitating bilateral trade in a number of key areas. Since the MRA essentially regulates the uniform market access and dynamic alignment with EU regulations, and these form the core of the Institutional Framework Agreement between the EU and Switzerland negotiated since 2014, the MRA falls within its scope. From the EU’s point of view, an update of the MRA is not possible without simultaneous consent on the Institutional Framework Agreement.

Since the EU’s new Medical Devices Regulation entered fully into force in full on 26 May 2021 and large parts of it are not included in the existing MRA, some of the trade facilitations contained therein will no longer apply until an agreement is reached on the amendment of the MRA. This concerns in particular the mutual recognition of the conformity assessment results, the waiving of an authorised representative and the alignment of technical regulations.

The following points should therefore be observed in future:

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Authors

Dr. Marco Stief

Partner

Attorney-at-Law

LL.M. University of Chicago

Head of Legal Department