Switzerland is not an EU Member State, however it is linked with the EU via bilateral treaties. In the period of 2014 to 2018, the EU and Switzerland had been negotiating on a proposal that would include free movement of persons, air transport, carriage of goods and passengers by rails and road, trade in agricultural products and mutual recognition of standards. However, the free movement of persons was rejected in a public referendum and ever since the compromise has not been found.
This is problematic as the Medical Device Directives (MDD) are covered by the Mutual Recognition Agreements (MRA), however, this is not certain for the Medical Device Regulation (MDR), as the MRA for the MDR will only be signed if there is an agreement on the bigger treaty and this might be a lengthy process.
In case the MRA is agreed, the MRA would be updated to include the MDR and harmonized approach would simply continue. Nevertheless, the possibility of a negative result, i.e. a ‘’Swexit” was announced already in April 2019 by Swiss Medtech. Recently, Swiss MedTech issued a warning that Swiss manufacturers should prepare for a “realistic worst-case scenario”.[1]
The impact of ‘Swexit’
If a “worst-case scenario” was actually to happen, Swiss manufacturers will have to meet third country requirements. In this case, for them to place medical devices on the EU market after 26 May 2020:
• Swiss manufacturer will have to designate a European Authorized Representative, with a Person Responsible for Regulatory Compliance (PRRC) and an importer based in the EU;
• Medical devices manufactured (or redesigned) in Switzerland would be “imported” into the EU. Swiss Medtech already confirmed that this concerns all devices, including devices with certificates issued under the Directives[1];
• Non-EU manufacturers with Swiss EAR will have to find a new one, that is established in one of the 27 EU Member States. Alternatively, Swiss established EARs will have to relocate to an EU Member State;
• Medical devices that have been CE Marked by a Swiss Notified Body can no longer be placed on the EU market from 26 May 2020;
• Labelling and packaging would have to be changed accordingly.
Recommended Steps for Swiss manufacturers in order to export into the EU:
• Appoint an EAR within the EU, as well as an EU based PRRC;
• Find an importer;
• Change labelling and packaging accordingly.
Recommended Steps for non-EU manufacturers importing into the EU that have a Swiss EAR and/or importer:
• Appoint a professional EAR, such as Obelis, that is based in the EU. The labels and packaging must be changed accordingly.
Swiss Medtech has also announced to publish a guide for the EU manufacturers that export into Switzerland.
With this being said, it is clear that the MRA could still be signed. If it does get signed, the only remaining concern would be if it will be signed before or after May 26. Manufacturers should therefore, prepare alternative labellings and be ready to launch on a short notice.
Nika Gavrilovic
Regulatory department
12.02.2020
For further information, contact our Regulatory Experts!
[1] https://3f523920-8cff-4a1c-8866-b188e9556a2b.usrfiles.com/ugd/3f5239_81ac77c6ade747c293171385b289b07b.pdf
[2] https://static.wixstatic.com/ugd/3f5239_aa23db2388df48519eecfe729c9cbc79.pdf