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.

The longer-term registration process for medical devices in Switzerland is unknown.

If the Swiss Federal Council implements a new framework agreement with the EU Commission, then use of EUDAMED will become mandatory again in Switzerland. However, if Switzerland and the EU cannot come to terms on a new agreement, then Switzerland may need to amend the MedDO and IvDO to remove references to EUDAMED.

Swissdamed

In the meantime, Swissmedic is developing its own EUDAMED-like registration database, called Swissdamed. It is expected to launch in 2023 and will consist of two registration modules:

    1. Economic Operators
    2. Medical Devices

Per Swissmedic, they will align with EUDAMED:

Due to the continuing aim of equivalence between regulations in Switzerland and the EU, the swissdamed modules will be similar to the corresponding EUDAMED modules.

For more information, please read: Swiss Registration Database (Swissdamed)

Download our Easy-to-Read infographic:  Steps to Enter the Swiss Market

Medical Device and IVD Registration Requirements

Until Swissdamed is launched, only a limited number of devices require registration. 

The current registration requirements are outlined on Swissmedic’s website: medical devices, IVDs

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).

IVDs

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).

Systems/Procedure Packs

Only applicable to assemblers based in Switzerland; Swiss ARs are not obligated to notify system/procedure packs on behalf of third country manufacturers.

Custom-made Devices

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.