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.