Quick answer

What is a CH-REP Swiss authorised representative?

A CH-REP (Swiss Authorised Representative) is the mandatory in-country contact for manufacturers without a registered place of business in Switzerland under the revised Medical Devices Ordinance (MedDO). The CH-REP verifies EU Declaration of Conformity or Swiss conformity documentation, registers devices with Swissmedic where required, maintains technical documentation availability, reports incidents, and cooperates with Swissmedic on post-market obligations on behalf of the foreign manufacturer.

Swiss Authorised Representative (CH-REP) for Medical Devices – Swissmedic Obligations

Legal Requirement and Purpose

Since the entry into force of the revised Medical Devices Ordinance (MedDO) on 26 May 2021, manufacturers without a registered place of business in Switzerland must appoint a Swiss Authorised Representative (CH-REP) to place their medical devices on the Swiss market. The CH-REP acts as the legal entity in Switzerland responsible for ensuring regulatory compliance on behalf of the foreign manufacturer, similar to the role of an EU Authorised Representative under MDR/IVDR. This requirement strengthens market surveillance, traceability, and direct communication with Swissmedic. CH-REP – Swissmedic

Who Needs a CH-REP

A CH-REP is mandatory for:

• All non-Swiss manufacturers placing devices of any class (including custom-made and investigational devices under certain conditions) on the Swiss market.
• Importers and distributors are not required to act as CH-REP unless they assume manufacturer obligations.

Swiss-based manufacturers do not need a CH-REP.

Appointment and Designation

• The foreign manufacturer must formally designate the CH-REP via a written mandate/agreement.
• The CH-REP must be a natural or legal person established in Switzerland with sufficient competence and resources.
• The designation must be documented and made available to Swissmedic upon request.

The CH-REP's details (name, address, contact) must appear on the device labelling, instructions for use, and declarations of conformity.

Key Responsibilities of the CH-REP

The CH-REP assumes the following obligations on behalf of the manufacturer:

• Technical Documentation: Keep available for Swissmedic for the required retention period.
• Vigilance and Post-Market Surveillance: Handle incident reporting, field safety corrective actions, and trend reporting.
• Registration: Support or perform registrations in the Swiss medical devices database (including UDI data where applicable).
• Liaison: Serve as the primary contact for Swissmedic enquiries and inspections.
• Compliance Monitoring: Ensure ongoing conformity with MedDO requirements, including updates to labelling and documentation.
• Language: Ensure Swiss-required language versions (German, French, Italian) are available.

The manufacturer remains ultimately responsible for device safety and compliance; the CH-REP acts as a mandated agent.

Practical Considerations

• Multiple manufacturers may appoint the same CH-REP.
• Changes in CH-REP designation require prompt notification to Swissmedic and update of affected documentation/labelling.
• Swissmedic provides guidance on mandate templates, minimum competence requirements, and a public list of registered CH-REPs for verification.

This mandatory CH-REP system aligns Switzerland's framework with international standards while ensuring effective national oversight and patient safety for imported medical devices. Detailed obligations, mandate examples, and contact information are available on the Swissmedic CH-REP dedicated page. CH-REP – Swissmedic

Frequently asked questions

What is CH-REP? CH-REP is the Swiss equivalent of an EU Authorised Representative—a legal entity in Switzerland appointed by a non-Swiss manufacturer to fulfill MedDO obligations.

When is CH-REP mandatory? Manufacturers without a Swiss registered address must appoint a CH-REP before placing medical devices on the Swiss market under MedDO.

What are CH-REP obligations? Registration support, documentation custody, incident reporting, cooperation with Swissmedic, and ensuring device conformity and labeling meet Swiss requirements.