Medical Device & IVD Registration in Switzerland 

Background

Before the Mutual Recognition Agreement ( MRA ) with Europe lapsed, and when they still believed the ‘Swixit / Swexit’ situation would be resolved, Switzerland amended their Medical Device Regulation (Ordinance: MedDO) to align with the new EU Medical Device Regulation (MDR). However, Switzerland and the EU ultimately could not come to terms, and the MRA was not updated to include mutual recognition of the MDR. The same situation occurred on the IVDR’s date of application, and IVDR was also not incorporated into the MRA.

This left Switzerland as a ‘Third Country’, with no Swiss–EU mutual recognition agreement for medical devices and IVDs.

The MDR requires that manufacturers register their devices (all risk classes) into the EU’s medical device database ( EUDAMED ). The Swiss MedDO and IvDO also requires this. This is problematic since Switzerland, now a Third Country, no longer has competent authority level access to EUDAMED, and therefore cannot utilize EUDAMED – as their own legislation requires them to do. The EU Commission’s EUDAMED FAQs confirms that Switzerland’s access has been removed.

Currently this is not a catastrophic issue, since EUDAMED has been delayed until Q2 2023 and is not mandatory yet. Only some modules have been released for use, and only on a voluntary basis. Until EUDAMED is functional and mandatory, the requirements of the old Directives continue to apply.

Therefore, 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 may be a reality for Switzerland. However, if Switzerland and the EU cannot come to terms on a new agreement, then Switzerland will likely need to amend the MedDO and IvDO to remove references to EUDAMED and develop its own device notification system.

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

The devices that need Swiss registration are:

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

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).

Made by the manufacturer, Authorized Representative (CH-REP), importer or distributor in Switzerland before making the product available on the market.

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

Economic Operator Registration in Switzerland 

Background

The Swiss MedDO 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“.

Despite citing the MDR/IVDR, 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 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.)

Further deviating from the MDR/IVDR, while EUDAMED is currently voluntary, Swissmedic has made obtaining the CHRN mandatory for Swiss-based manufacturers, authorized representatives and importers.

We anticipate further developments in the registration process as Swissmedic determines how to navigate the fact that they no longer have access to EUDAMED.

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