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.
Switzerland is not a member of the European Economic Area (EEA), which includes the 27 EU member states + Iceland, Liechtenstein and Norway. However, since 2002 Switzerland has had access to the EEA through a series of mutual recognition agreements. The first series of Agreements, the so-called “Bilateral Agreements I”, covers many industries, including medical devices.
“Bilateral Agreements I” specifically refers to the EU’s medical device Directives (MDD / AIMDD / IVDD). The MDR and IVDR are not covered. However, they could theoretically be covered through an amendment to “Bilateral Agreements I”. This would allow continued mutual recognition of devices under the MDR and IVDR. But this did not happen.
By of the MDR date of application (26 May 2021), the Swiss Federal Council and the EU Commission failed to come to terms on a new overarching framework agreement. As a result, the EU Commission responded that the EU would not update the existing MRA to include the MDR/IVDR. This suddenly turned Switzerland into a ‘third country’ as it related to the MDR. The same is true when the IVDR date of application occurred (26 May 2022).
‘Swixit’ / ‘Swexit’ negotiations, unlike ‘Brexit’, received less international coverage but have similar long-term trade implications for the medical device industry.
Lacking a valid MRA, Swissmedic implemented the below requirements for manufacturers to continue selling medical devices and IVDs in Switzerland:
Appoint a Swiss Authorized Representative
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.
Identify a Swiss Importer
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.
Swiss importers, like the Swiss AR, require a Swiss Single Registration Number ( CHRN ).
Register Devices with Swissmedic
Without an MRA in place, and therefore no administrative access to EUDAMED , Switzerland must develop its own “EUDAMED-like” medical device registration database. Swissmedic is in the process of building such a platform, and has stated that “Due to the continuing aim of equivalence between regulations in Switzerland and the EU, the medical devices database will be similar to EUDAMED.”
In the meantime, industry should follow the registration process as it stands today. Additional information on this topic can be found on our Swiss medical device registration page.
Currently, only Swiss manufacturers require a Swiss Single Registration Number (CHRN). As mentioned earlier in this page, this is unlike the EU MDR/IVDR, which requires all manufacturers obtain an EU Single Registration Number (SRN), irrespective of where they are located.
NOTE: Switzerland still fully recognizes European CE Marking, including certificates issued by European Notified Bodies.