Since 26 May 2021, with the full application of the Medical Device Regulation MDR (EU) 2017/745 and having not reached an institutional agreement, Switzerland is officially considered a “Third Country” for Europe.
This means that Swiss Manufacturers must appoint a European Authorised Representative to export their devices to Europe. At the same time, European Manufacturers must designate a Swiss Authorised Representative to export their products to Switzerland, in compliance with the Medical Device Ordinance (MedDo).
The institutional agreement between Switzerland and the EU has not been reached because the Mutual Recognition Agreement (MRA), that is one of the essential preconditions for unfettered free trade of goods, has not been updated as, according to the Swiss Federal Council, there remain substantial differences on some key issues between Switzerland and the EU such as to make the breakdown of negotiations with the European Union necessary. Despite this, Associations and Regulatory Authorities will continue to work with unwavering commitment to ensure that the MRA is updated as quickly as possible so that Switzerland’s relations with the EU can rest once again on a solid and lasting foundation.
In the meantime, Medical Devices placed on the Swiss market must comply with the MedDo (modified in May 2021), which sets numerous requirements.
The timelines for affixing the UDI (Art. 17 paragraph 2) listed in Art. 104 MedDo are the following:
- from 26 May 2021 for implantable devices and class III devices;
- from 26 May 2023 for class IIa and IIb devices
- from 26 May 2025 for class I devices;
- 2 years after the dates given in letters a – c for the relevant product class for reusable devices subject to direct marking (where the UDI has to be affixed to the device itself).
Art. 104a provides for transition periods for the appointment of a Swiss Authorised Representative. If the Manufacturer is domiciled in an EU or EEA (European Economic Area) State or has designated an authorised representative domiciled in an EU or EEA State, that manufacturer must designate a Swiss Authorised Representative for all devices that have been placed on the market after May 26, 2021, within the following time periods (Art. 51 paragraph 1):
- by 31 December 2021 for class III devices, class IIb implantable devices and active implantable devices;
- by 31 March 2022 for non-implantable classe IIb devices and class lla devices;
- by 31 July 2022 for class I devices.
For systems and procedure packs, a Swiss Authorised Representative must be appointed by 31 July 2022 (Art. 51 paragraph 5).
For full details you can refer to the Medical Device Ordinance (MedDo).
The Swiss government has announced that the extension period will also apply on its territory in the manner set out in Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain Medical Devices and in vitro diagnostic Medical Devices. This measure formalises and makes immediately enforceable in Europe the third transitional period for compliance with MDR (EU) 2017/745.
Thus, it will be possible to place CE-marked Medical Devices in Switzerland until 31/12/2027 and 31/12/2028, depending on the risk class and type of device. Specifically:
- class III and IIb implantable devices can be marketed until 31/12/2027;
- class IIa and I devices until 31/12/2028.
Swissmedic has also published an information sheet on the use of the CH-REP symbol that indicates the Authorised Representative in Switzerland. The symbol can be downloaded on the website Swissmedic.
We remind you that Manufacturers that do not have a registered place of business in Switzerland, must appoint a Swiss Authorised Representative to place devices on the Swiss market.
If you market Medical Devices in Switzerland, Thema experts are ready to provide you with the right support through the following services:
- EU Authorised Representative
- Swiss Authorised Representative
- Device registration in the Swissmedic database
- Device registration in Eudamed (Actors module) and European Ministries of Health