EU MDR - what’s happening with Switzerland?
Before 26th May 2021, medical devices had restriction-free movement between Switzerland and the EU market. Since MDR was fully implemented throughout Europe from 26th May 2021, and with the breakdown of talks between Switzerland and the EU Commission, Switzerland is now a ‘Third Country’.
This has consequences with Swiss MedTech manufacturers being treated like any other non-EU entities. Swiss manufacturers will now have to appoint an EU Authorised Representative in order to continue trading with the EU. If they sell into Great Britain, they will also need a UK Responsible Person. The flip side to all this is that EU and UK MedTech companies selling into Switzerland must now appoint a Swiss Authorised Representative to maintain their supply chain.
Apart from all other devices, ‘legacy devices’ certificates are also affected as they rely on the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD). There is already evidence that Swiss MedTech companies are being excluded from Europe because their devices have been certified by a Swiss Notified Body under MDD/AIMDD which the EU Commission will not accept as being covered by the MDR transitional provisions.
Despite Switzerland being a European country, it is not part of the European Union (EU). Switzerland is a part of the European Free Trade Association (EFTA), together with the three countries that make up the European Economic Area (EEA). The EEA automatically follows all EU product legislation, so EFTA is not bound to that requirement. Trade with Switzerland is established via multiple mutual recognition agreements.
Until 26th May 2021, there existed a Mutual Recognition Agreement (MRA) between Switzerland and the EU for the AIMDD and MDD. This MRA ended with the application of MDR. Both sides have drawn up an MRA covering the MDR that is complete and ready to be signed. However, that new MRA is linked to another agreement with a broader scope, the Institutional Framework Agreement (“InstA”). This new InstA was voted down in one of the Swiss referendums, and thus the MRA for the MDR is unable to take effect.
Briefly: without entire EEA or EU membership, InstA is needed; without sufficient support from the Swiss voters, there is no InstA; without InstA, there is no MRA; without this MRA, Switzerland is a third country for medical devices.
EU perspective: Switzerland as a third country
Switzerland’s third country status is well understood by Swiss manufacturers or non-EU manufacturers relying on a Swiss Authorised Representative (AR) and/or importer. These manufacturers must be sure to appoint an EU-based AR and/or importer in line with Article 11 and Article 13 of the MDR. Although the role of Switzerland in the EFTA has not changed, and the movement of trade is supposed to still be relatively frictionless, it is crucial to make sure that economic operators are in place according to the MDR.
Swiss perspective: All countries as Third countries
Because of the absence of MRA, medical devices placed on the EU market do not have access to the Swiss market. In order to secure their space on the Swiss market, medical devices should fully comply with the new law introduced in 2020 by Switzerland, the Medical Devices Ordinance or MedDO. This law was amended in May 2021.
Article 104a of the amendment provides for extra time for designating the Swiss AR in case of EU- or EEA-based manufacturers or manufacturers that rely on an AR-based in the EU or EEA:
- For Class III devices, Class llb implantable devices, and active implantable devices, the Swiss AR must be designated by 31st December 2021.
- For Class llb non-implantable devices and Class lla devices, the Swiss AR must be designated by 31st March 2022.
- For Class I devices, the Swiss AR must be designated by 31st July 2022.
These longer lead-in times do not apply to the importer. It is unclear whether the Swiss AR and/or importer must be listed on the product label or instructions for use (IFU).
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