Switzerland outside EUDAMED – a standalone registration pathway

Because no Mutual Recognition Agreement (MRA) with the European Union is in force, Switzerland has no access to EUDAMED. Medical-device and IVD registrations follow national regulations: the MedDO (SR 812.213) for medical devices and the IvDO (SR 812.219) for in-vitro diagnostics. Any manufacturer located outside Switzerland must complete an independent procedure with Swissmedic, the national competent authority. That process covers a technical-documentation review, appointment of a CH-REP and compliance with Swiss labelling and distribution rules.

CH-REP – the Swiss authorised representative

A CH-REP is a natural or legal person established in Switzerland who holds a written mandate from a non-Swiss manufacturer to represent it on the Swiss market. The obligation derives directly from MedDO/IvDO and applies to every manufacturer without a Swiss address, whether based in the EU, the UK or a third country.

CH-REP details must appear on the device label or accompanying documentation, alongside the importer’s data. The representative is the formal contact point for Swissmedic, users and patients.

CH-REP duties – far more than a formality

The CH-REP must verify the device’s compliance with MedDO or IvDO and hold access to the manufacturer’s technical documentation. Tasks include keeping information up-to-date, responding to Swissmedic enquiries and coordinating post-market-surveillance (PMS) activities.

The manufacturer–CH-REP relationship must be laid down in a written agreement that reflects Article 51(2) MedDO. Unlike an EU REP or UK RP, the CH-REP’s mandate is limited to Switzerland and governed solely by Swiss law.

Appointing a CH-REP – steps to plan carefully

The appointment is based on a signed contract defining the representative’s responsibilities for conformity assessment, regulatory communications and PMS. Only after the contract is executed may the CH-REP’s particulars be placed on labels or IFU. Having an EU REP does not waive the CH-REP requirement—the roles are separate and legally distinct.

Device registration – sequence of actions

  • CH-REP review of the technical file
  • Preparation of labels meeting MedDO/IvDO rules
  • Notification of CH-REP and importer data to Swissmedic (where applicable)
  • Placing the CE-marked device on the Swiss market with visible CH-REP details

Switzerland accepts the EU Declaration of Conformity issued under MDR or IVDR, so no separate Swiss DoC is required. The transitional Regulation EU 2023/607 is also recognised by Swissmedic.

Post-market surveillance and local responsibility

The CH-REP plays a key role in PMS: reporting incidents, IFU changes, safety notices and corrective actions. Continuous, documented cooperation with the manufacturer is mandatory. MedDO/IvDO non-compliance—even if MDR is met—can block market access.

How Pure Clinical supports Swiss MD & IVD registration

Pure Clinical provides end-to-end assistance for MedDO/IvDO compliance and Swiss registration. Acting as your CH-REP, we ensure full alignment of documentation, labelling, communications and surveillance with Swissmedic expectations.

  • Technical-file and MedDO/IvDO conformity review
  • Selection and appointment of a CH-REP with Article 51(2)-compliant agreement
  • Preparation of Swiss-compliant labels and IFUs
  • Swissmedic notifications where required
  • PMS and incident coordination via CH-REP
  • Pre-registration audits and market-entry support

We assist EU and non-EU manufacturers alike, regardless of device class or dossier complexity.

FAQ

What is a CH-REP and who must appoint one?

A CH-REP (Swiss Authorised Representative) is a natural or legal person based in Switzerland, formally authorised in writing by the manufacturer to represent it on the Swiss market. Appointing a CH-REP is mandatory for any manufacturer of medical devices or IVDs that is not established in Switzerland — regardless of whether it is based in the EU, the UK or a third country.

Does having an EU Authorised Representative (EU REP) exempt a manufacturer from appointing a CH-REP?

No. Having an EU REP does not exempt a manufacturer from the obligation to appoint a CH-REP - these are two independent roles governed by separate regulations. The CH-REP operates exclusively within Switzerland and is subject to the Swiss MedDO and IvDO regulations.

Why doesn’t Switzerland use the EUDAMED database?

Because the Mutual Recognition Agreement (MRA) between Switzerland and the European Union expired in May 2021. Since then, Switzerland has had no access to the EU single market for medical devices and registers devices locally under its own MedDO and IvDO regulations.

What are a CH-REP’s responsibilities towards Swissmedic?

A CH-REP is responsible for verifying the device's compliance with the MedDO/IvDO, ensuring access to the manufacturer's technical documentation, responding to Swissmedic's enquiries, and coordinating post-market surveillance activities, including incident reporting and safety notices.
 

Does the Swiss declaration of conformity need to differ from the EU one?

No - Switzerland accepts the EU declaration of conformity issued under the MDR or IVDR. It also recognises the EU transitional Regulation (EU) 2023/607, which makes it easier for manufacturers to place devices on both markets in parallel.

What is swissdamed and when did it become mandatory?

Swissdamed is the Swiss equivalent of the EU's EUDAMED database, operated by Swissmedic. Mandatory registration in the system took effect on 1 July 2026 for new devices, with a transition period for devices already on the market running until 31 December 2026.

Does registration in EUDAMED exempt a manufacturer from registering in swissdamed?

No. The two systems are independent of each other, so manufacturers selling devices in both the EU and Switzerland must register them separately - in EUDAMED and in swissdamed, each according to its own applicable deadlines.

What is the sequence of steps for registering a device in Switzerland?

The process includes verification of the technical documentation by the CH-REP, preparation of labelling compliant with the MedDO or IvDO, submission of the CH-REP's and importer's details to Swissmedic, and placing the device on the market with CE marking and visible CH-REP details.
 

What happens if a device does not comply with the MedDO or IvDO despite holding a CE certificate?

A CE certificate and MDR compliance alone are not sufficient — failure to meet the local MedDO/IvDO requirements can lead to the device being refused market access in Switzerland, regardless of its regulatory status in the European Union.
 

How does Pure Clinical support manufacturers registering devices in Switzerland?

Pure Clinical verifies the technical documentation's compliance with the MedDO/IvDO, selects and appoints a CH-REP together with the underlying agreement, prepares labelling and IFU compliant with local requirements, submits data to Swissmedic, and coordinates post-market surveillance activities and pre-registration audits.