Why is a CH-REP necessary for medical device manufacturers?

Due to the non-update of the EU-Switzerland Mutual Recognition Agreement (MRA) to include the EU MDR, non-Swiss manufacturers must appoint a Swiss Authorized Representative (CH-REP) to act as their liaison with Swissmedic, as mandated by MedDO Article 51.

What are key Swiss-specific labeling requirements?

Swiss labeling requirements generally include details like the CH-REP information, and specific language considerations may apply, often requiring labels in the national languages of German, French, and Italian, as per MedDO requirements.

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Swissmedic

Swiss medical device regulator; Switzerland is now a third country to the EU under MDR.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

Definition

Swissmedic enforces the Swiss Medical Devices Ordinance (MedDO), which mirrors most of EU MDR. Since the EU-Swiss Mutual Recognition Agreement was not updated for MDR, manufacturers need a Swiss Authorized Representative (CH-REP) and Swiss-specific labeling. The IVD rules sit in a parallel ordinance, the In Vitro Diagnostic Medical Devices Ordinance (IvDO), which closely follows the IVDR. Swiss importers carry their own obligations, and Switzerland unilaterally recognizes CE certificates issued by EU notified bodies, so a separate Swiss conformity assessment is usually not needed.

What the regulation says

Swissmedic is the Swiss Agency for Therapeutic Products, equivalent to the FDA in the United States or a national Competent Authority within the European Union. It is responsible for authorizing and supervising therapeutic products, including medical devices, in Switzerland. Swissmedic enforces the Medical Devices Ordinance (MedDO), which aligns with many principles of the EU Medical Devices Regulation (EU MDR), as outlined in Article 10 of MedDO.

What this means in practice

Often overlooked when planning EU launches; missing CH-REP or labeling routinely blocks Swiss commercialization.

Examples

A German manufacturer planning to sell a Class IIa device in Switzerland must appoint a CH-REP and ensure their device labeling includes the CH-REP's details and meets Swiss language requirements, even if it is fully CE-marked.
An American company, already compliant with EU MDR, discovers during their Swiss market entry planning that they need to revise their instruction for use (IFU) and device labels to include specific Swiss-mandated symbols and information about their CH-REP.
A MedTech startup developing innovative software as a medical device (SaMD) for both EU and Swiss markets allocates specific resources to understand and implement Swissmedic’s unique registration and post-market surveillance requirements, beyond their EU MDR efforts.

Common pitfalls

•A common pitfall is assuming that EU MDR compliance alone is sufficient for market access in Switzerland, neglecting the specific Swiss requirements.
•Manufacturers often overlook the need for a designated Swiss Authorized Representative (CH-REP) before placing devices on the Swiss market.
•Failing to implement Swiss-specific labeling requirements, such as language and symbol variations, can lead to market access delays.
•Confusion regarding the status of the EU-Switzerland Mutual Recognition Agreement (MRA) post-EU MDR implementation can result in non-compliance.

Frequently asked questions

Swissmedic is the national regulatory authority responsible for ensuring the safety and efficacy of medical devices marketed in Switzerland, overseeing their authorization and post-market surveillance activities.

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Link health: 3 verified· last checked 2026-06-20

Swissmedic·1European Commission·1IMDRF·1

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Updated: 9/19/2026

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Swiss medical device regulator; Switzerland is now a third country to the EU under MDR.

·Often overlooked when planning EU launches; missing CH-REP or labeling routinely blocks Swiss commercialization.
·Since the EU-Swiss Mutual Recognition Agreement was not updated for MDR, manufacturers need a Swiss Authorized Representative (CH-REP) and Swiss-specific labeling.
·The IVD rules sit in a parallel ordinance, the In Vitro Diagnostic Medical Devices Ordinance (IvDO), which closely follows the IVDR.

Remember this

Watch out: A common pitfall is assuming that EU MDR compliance alone is sufficient for market access in Switzerland, neglecting the specific Swiss requirements.

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