The agreement between Switzerland and the European Union on mutual recognition in relation to conformity assessment (MRA) of medical devices started in June 2002 and ended in May 2021. The MRA aimed to facilitate the trade between Switzerland and the European Union and applied to various sectors, including medical devices.
Discussions on trade relations between Switzerland and the EU
The Swiss Federal Council is currently addressing the necessity to establish again mutually beneficial single market agreements with the EU. In these terms, the Swiss side has already prepared the basis for exploratory talks on many different sectors, from electricity to food, from education to health. Especially in the field of medical devices, mutual recognition is crucial for Switzerland. The country cannot manufacture the amount of medical devices necessary for their domestic needs and complex trade relations can negatively impact the supply.
What a lack of mutual agreements means for IVD and medical devices
A mutual recognition agreement between Switzerland and the EU could have granted a smooth alignment of the Swiss medical legislation with the new EU Regulations for medical devices (MDR and IVDR). The interruption of the MRA has had many consequences. Switzerland has been considered a third country for medical devices as of May 26, 2021. While for IVDs, the MRA chapter remains valid until the IVDR date of application – May 26, 2022. Without an update to the MRA, IVD manufacturers will face the same situation as their medical device counterparts. Together with the obligation to mandate a Swiss Authorised Representative, manufacturers of medical devices who want to sell in Switzerland must respect other obligations, such as a registration to Swissmedic, and further labelling requirements.
Timeline and steps to place your medical devices on the Swiss market
Last year, the Swiss Federal Council has given foreign manufacturers of medical devices additional time to mandate a Swiss Authorised Representative (deadlines can be found here). Nonetheless, this might not prevent the shortage of medical devices. For class III devices, class IIb implantable devices, and all active implantable devices, the deadline to appoint a Swiss Authorised Representative was December 31, 2021. For Class IIb and Class IIa medical devices, the deadline is March 31, 2022, and for Class I devices & systems and procedure packs July 31, 2022.
If you want to place your medical devices on the Swiss market, you need to consider, among others, the following steps:
- Appoint of a Swiss authorised representative (mandatory for any non-Swiss manufacturer);
- Registration and notification via Swissmedic (Switzerland is not using EUDAMED);
- Registration for economic operators in three months following the placing of a device on the Swiss market.
For IVDs, the final Swiss Ordinance on IVDs has not yet been published. Nevertheless, Swiss Medtech recently shared a timeline for designation of a Swiss Authorized Representative for:
- Class D devices by December 31, 2022
- Class C and B devices by March 31, 2023
- Class A devices by July 31, 2023
The above is still subject to Federal Council decision.
You can consult the draft law in our dedicated Library of Documents – Switzerland.
Schweizer Eidgenossenschaft. (2022). Bericht an den Bundesrat. Regelungsunterschiede zwischen dem Schweizeri-schen Recht und dem Recht der Europäischen Union. Retrieved on 15/03/2022 from
Schweizer Eidgenossenschaft. (2022). EU relations: Federal Council sets out approach for negotiations. Retrieved on 15/03/2022 from https://www.eda.admin.ch/europa/en/home/aktuell/medienmitteilungen.html/content/eda/en/meta/news/2022/2/25/87349.
Swiss Medtech. (2022). Drohende Versorgungsdefizite bei Medizinprodukten in der Schweiz. Retrieved on 15/03/2022 from https://www.swiss-medtech.ch/sites/default/files/2022-03/20220309_VersorgungsdefiziteCH_LSR_202202_Sch%C3%BCtz_Bichsel.pdf
Swiss Medtech. (2022).. Retrieved on 16/03/2022 from https://www.swiss-medtech.ch/sites/default/files/2022-02/IvDO-dates_EN.pdf