How to sell your medical devices and IVDs in Switzerland
On 26 May 2021, the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) ceased to be recognized for medical devices, and on 26 May 2022 for IVDs.
As of those dates, non-Swiss manufacturers are required to appoint a Swiss Authorized Representative in order to place devices onto the Swiss market. As well, Swiss manufacturers must appoint a European Authorized Representative in order to place devices on the EU market.
Lacking a valid MRA, Swissmedic implemented the below requirements for manufacturers to continue selling medical devices and IVDs in Switzerland:
1) Appoint Swiss Authorized Representative (CH-REP)
Manufacturers not located in Switzerland must appoint a Swiss Authorised Representative (CH-REP) that is located in the country. This is a new and separate role from the EU Authorised Representative (EC-REP). For manufacturers with CE marked devices already on the market before the MDR/IVDR dates of application, the CH-REP must be appointed by the following deadlines:
Class IIb implantable, Class III, and AIMD – 31 December 2021
Class IIb non-implantable, Class IIa – 31 March 2022
Class I, systems and procedure packs – 31 July 2022
Class D IVDs – 31 December 2022
Class C, B IVDs – 31 March 2023
Class A IVDs – 31 July 2023
For manufacturers that do not meet the above criteria, the Swiss representative must be appointed immediately. In other words, if you are newly entering the market, then you must comply with the Swiss Authorized Representative (AR) requirement immediately, as the transition period does not apply.
The Swiss AR and manufacturer must put in place a Mandate form with each entity’s company name and address identified. The AR may optionally submit the Mandate to Swissmedic, though is not required to do so.
Read more about this topic here: Switzerland Authorized Representative
*Due to a customs treaty between Switzerland and Liechtenstein, a manufacturer located in Liechtenstein is not required to appoint a Swiss AR.
2) Identify Swiss Importer(s)
As outlined in the Swissmedic’s ‘Obligations Economic Operators CH’, the Swiss importer is not ‘designated’ into that role by the manufacturer. Instead, whichever entity within the supply chain that first ‘places the product on the market’ is considered the importer.
Similar to the EU MDR/IVDR, the Swiss importer information must be supplied with the device, either on the device labeling, instructions for use, or in a ‘document accompanying the device’. However, unlike the EU MDR/IVDR, Swissmedic’s interpretation of a ‘document accompanying the device’ is expanded to include: a delivery note, guarantee certificate, customs documents or invoice. Further, Swissmedic does not require that the ‘document accompanying the device’ reach the end user, while the MDR/IVDR does require this.
In another shift from the EU requirements, Swiss importers are required to identify themselves with MDD/AIMDD/IVDD CE marked products, aka ‘legacy’ devices. This is a deviation from the European guidance documents MDCG 2021-25 (medical devices) and 2022-8 (IVDs), which does not require an importer identify themselves with legacy devices. Swissmedic offers a transition period to identify the importer for legacy medical devices: 31 July 2022. A transition period is not provided for IVD legacy devices.
Swiss importers of MDR/IVDR CE marked devices should have identified themselves with the device as of 26 May 2021 (MDR) and 26 May 2022 (IVDR), or within three months of having first placed the product onto the Swiss market.
3) Register Devices with Swissmedic
Without an MRA in place, and therefore no administrative access to EUDAMED, Switzerland will develop its own medical device registration database, called Swissdamed. It is expected to launch in 2023 and per Swissmedic, it “will be similar to the corresponding EUDAMED modules.”
In the meantime, industry should follow the registration process as it stands today. For more information, please read: Swiss Medical Device Registration
NOTE: Switzerland still fully recognizes, and requires, European CE Marking. This includes recognizing certificates issued by European Notified Bodies.