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:
- For all new products, Swiss manufacturers will be treated like all other manufacturers from third countries who want to place their products on the EU market. In particular, new Swiss products with medium and high risk 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 being valid in the EU.
- For existing certificates issued under the MRA by conformity assessment bodies established in the EU, Swiss producers and producers from third countries whose authorised representative was previously established in Switzerland, must now appoint an authorised representative who is established in the EU.
- On 19 May 2021, the Swiss Federal Council adopted an amendment to the Swiss Medical Devices Ordinance. This sets out the conditions for trading on the Swiss market in medical devices covered by certificates that were issued in the EU. This comprises the recognition of existing certificates issued under the MRA by conformity assessment bodies established in the EU and transitional periods for the appointment of a representative in Switzerland for EU/EEA manufacturers of medical devices.
Our blog contributions shall provide an overview with regard to legal topics, legislation and case law and are supposed to provide some general information rather than constituting any specific advice. Please do not hesitate to contact Maiwald and in particular the authors of the particular contributions if have any questions on the addressed topics or on other legal issues.