Switzerland Medical Device & IVD Registration Requirements
Due to larger political issues, the Switzerland-EU Mutual Recognition Agreement (MRA) has lapsed for medical devices and IVDs.
The Swiss regulations (MedDO and IvDO) require manufacturers to register in EUDAMED – however, now that Switzerland is a ‘third country’ from Europe, it no longer has access to EUDAMED. The EU Commission’s EUDAMED FAQs confirms that Switzerland’s access has been removed.
What does this mean for you?
What is the Status with EUDAMED?
Even though Swissmedic has lost access to EUDAMED, it is not a major issue since EUDAMED has been delayed. Only some modules are available and use is voluntary. Until EUDAMED is fully functional, the requirements of the old Directives continue to apply.
If the Swiss Federal Council implements a new framework agreement with the EU Commission, then use of EUDAMED will become mandatory again in Switzerland.
In the meantime, Swissmedic is developing its own EUDAMED-like medical device registration database, called ‘swissdamed’. It will consist of two registration modules:
- Economic Operators
- Medical Devices
It will launch in phases through 2023-2024.
For more information, please read: Swiss Registration Database (Swissdamed)
Medical Device and IVD Registration Requirements
Until swissdamed is launched, only a limited number of medical devices require registration in Switzerland.
Class I Medical Devices
Only applicable to Swiss manufacturers; Swiss Authorized Reprensentatives (CH-REPs) are not obligated to notify Class I devices on behalf of third country (i.e., non-Swiss) manufacturers, although the CH-REP is obligated to verify that the device complies with the Swiss medical device ordinance (MedDO).
Only applicable to Swiss manufacturers; Swiss Authorized Reprensentatives (CH-REPs) are not obligated to notify IVD medical devices on behalf of third country (i.e., non-Swiss) manufacturers, although the CH-REP is obligated to verify that the device complies with the Swiss medical device ordinance (IvDO).
Only applicable to assemblers based in Switzerland; Swiss ARs are not obligated to notify system/procedure packs on behalf of third country manufacturers.
Required for all custom-made devices. The registration is made by the manufacturer, authorized representative (CH-REP), importer or distributor in Switzerland before making the product available on the market.
Economic Operator Registration Requirements
Swissmedic defines an economic operator as “the manufacturer, authorised representative, importer, distributor or natural or legal person as specified in Article 22 paragraphs 1 and 3 EU-MDR“.
Swissmedic has deviated from the MDR/IVDR regarding economic operator registration requirements. Unlike the MDR/IVDR, which requires that all manufacturers, authorised representatives and importers register in EUDAMED, Swissmedic only requires the following to register themselves: manufacturers, authorized representatives and importers domiciled in Switzerland.
Meaning, while the MDR/IVDR requires all manufacturers, irrespective of where they are located, to register themselves, Swissmedic only requires Swiss manufacturers to complete the economic operator registration. Of course, this may change over time.
Swiss Single Registration Number (CHRN)
When an economic operator registers in EUDAMED, they are issued a Single Registration Number (SRN). When an economic operator registers with Swissmedic, they are issued a Swiss Single Registration Number, abbreviated as CHRN. (“CH” is the country abbreviation for Switzerland.)
In another deviation from the MDR/IVDR, while obtaining a SRN in EUDAMED is currently voluntary, Swissmedic has made obtaining the CHRN mandatory for Swiss-based manufacturers, authorized representatives and importers.