How to sell your medical devices & 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) Obtain CE Marking
Manufacturers must obtain CE marking for all medical devices and IVDs before the products can be sold in Switzerland. This process includes generating a technical documentation file (TDF) and quality management system (QMS) based on the requirements of the MDR/IVDR.
The TDF and QMS may further require review by a Notified Body. Notified Bodies are organizations accredited and supervised by the European national Competent Authorities. Their role is to evaluate if products have met the minimum safety and efficacy requirements.
Switzerland fully recognizes CE certificates issued by European Notified Bodies. If the device has been CE Marked in Europe, the manufacturer does not have to further action in regard to CE Marking. However, they must meet the additional requirements below.
2) Appoint Swiss Authorized Representative
Swissmedic provided the below transition period to appoint a Swiss AR, which has now ended:
- 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
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; however, it is not required to do so.
*Due to a customs treaty, Switzerland allows Liechtenstein-based companies to act as Swiss Authorized Representatives. Further, manufacturers and importers in Liechtenstein are exempt from having to appoint a Swiss Authorized Representative, though they must meet other obligations, such as obtaining a Swiss Single Registration Number (CHRN).
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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 will launch in 2024 and per Swissmedic, it “will be similar to the corresponding EUDAMED modules.”
In the meantime, Swissmedic only requires device registration for certain devices manufactured by Swiss manufacturers, such as Class I medical devices and IVDs. Non-Swiss manufacturers do not, and should not, register their devices* with Swissmedic.
*The exception is for custom-made devices, which should be registered irrespective of where the manufacturer is located.
4) Identify Swiss Importer(s)
An importer is the person (natural or legal) that first places a device from a third country onto the Swiss market.
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 Europe, 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 Europe 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.
Swiss importers should identify themselves with the device within three months of having first placed the product onto the Swiss market.