CH-REP in Switzerland: Key to Market Access for Medical Devices & IVDs

The Critical Role of the CH-REP in Swiss Market Access

Wednesday, 12 November 2025

CH-REP in Switzerland: Key to Market Access for Medical Devices & IVDs

7:30

If you are a manufacturer of medical devices or in vitro diagnostic (IVD) devices based outside Switzerland, understanding the role of the Swiss Authorised Representative (CH-REP) is essential for market access. Following revisions to the Swiss medical device law, the appointment of a CH-REP has become a mandatory step.

This post breaks down the key roles and responsibilities of this crucial economic operator, based on Switzerland's Medical Devices Ordinance (MedDO) and Ordinance on In Vitro Diagnostic Medical Devices (IvDO).

Why is a CH-REP Necessary?

Switzerland has updated its medical device legislation — the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) — to align with the European Union's regulations (MDR and IVDR).

Previously, the Mutual Recognition Agreement (MRA) between Switzerland and the EU provided equal market access. However, this agreement was not updated, leading Switzerland to establish its own set of measures to ensure device safety and market surveillance.

The most significant of these measures is the requirement for any manufacturer without a registered place of business in Switzerland—including those in the EU/EEA—to appoint a Swiss Authorised Representative (CH-REP) before placing their devices on the Swiss market.

What is a Swiss Authorised Representative (CH-REP)?

A CH-REP is defined as a natural or legal person domiciled in Switzerland who has received and accepted a written mandate from a manufacturer located in another country. This mandate empowers the CH-REP to act on the manufacturer's behalf for specific tasks outlined in the MedDO and IvDO.

The CH-REP is responsible for the formal and safety-related issues connected with the placing of the device on the Swiss market. The designation of the CH-REP must be effective for all devices within the same generic device group.

Qarad Suisse SA, part of QbD Group, provides a reliable Swiss-based presence, ensuring manufacturers meet all MedDO and IvDO obligations with efficiency and confidence.

Key Roles and Responsibilities of a CH-REP

The duties of a CH-REP are extensive and legally binding, as detailed in both the MedDO and IvDO.

1. Verification of Conformity and Documentation

Before a device is placed on the market, the CH-REP must verify that the manufacturer has drawn up the necessary EU Declaration of Conformity and technical documentation, and has carried out the appropriate conformity assessment procedures.

The CH-REP must also keep a copy of this documentation — including the Declaration of Conformity, technical documentation, and any relevant certificates — available for inspection by Swissmedic.

This documentation must be retained for at least 10 years after the last device has been placed on the market, and 15 years for implantable devices.

2. Registration with Swissmedic

All CH-REPs must register with Swissmedic to obtain a unique Swiss Single Registration Number (CHRN).

They are also required to verify that the manufacturer has fulfilled its own device registration obligations, and once this verification is complete, to register the mandate on the Swissdamed (the Swiss equivalent of EUDAMED).

3. Liaising with Competent Authorities

The CH-REP acts as the primary liaison with Swissmedic. Their duties include:

Forwarding any requests from Swissmedic for device samples or access to a device to the manufacturer.
Cooperating with Swissmedic on any preventive or corrective actions taken to eliminate or mitigate risks posed by devices.

4. Vigilance and Post-Market Surveillance

This is one of the most critical functions of a CH-REP. They play a key role in the post-market safety of a device:

They must immediately forward any complaints or reports from healthcare professionals, patients, or users about suspected incidents to the manufacturer.
Reporting serious incidents and field safety corrective actions that occur in Switzerland to Swissmedic. This responsibility must be explicitly laid out in the written mandate between the manufacturer and the CH-REP.
Submitting trend reports to Swissmedic for incidents occurring in Switzerland and abroad.

5. Changing the Authorised Representative

The process for changing a CH-REP must follow a clear procedure, as governed by the relevant articles in the EU regulations which are referenced in the Swiss ordinances.

At Qarad Suisse SA, we see the CH-REP mandate as more than a legal requirement. Acting as your Swiss Authorised Representative, we bring deep expertise in MedDO and IvDO, combined with extensive experience in MDR and IVDR.

This means you not only comply with Swiss legislation but also gain a partner who understands the practicalities of market access, regulatory communication with Swissmedic, and vigilance obligations.

By partnering with Qarad Suisse SA, you benefit from a team with strong regulatory expertise, well-established processes, and a clear understanding of Swissmedic expectations, ensuring smooth registration and reliable management of your compliance obligations in Switzerland.

Practicalities: How to Indicate/Reference the CH-REP

The manufacturer, CH-REP, and importer must be identifiable. The specific requirements for indicating the CH-REP vary by device type:

MDR Devices and IVDR devices for self-testing: The CH-REP must be indicated on the label.
IVDR Devices (not for self-testing): The CH-REP can be on the label or in a document accompanying the device.
"Legacy" Devices (under old MDD/AIMDD/IVDD directives): There are more flexible options, often allowing the CH-REP information to be included on the label, instructions for use, packaging, or in a document accompanying the device.

It is important to note that Switzerland's interpretation of a "document accompanying the device" can include delivery notes, invoices, or customs documents, and does not necessarily need to reach the end user. This differs from the European interpretation.

Conclusion

The appointment of a Swiss Authorised Representative is a legal mandate for any foreign manufacturer seeking to enter or remain on the Swiss market.

The CH-REP is not just a point of contact but a key partner responsible for crucial regulatory, safety, and vigilance functions. A clear, written mandate and a strong working relationship with a knowledgeable CH-REP are fundamental to ensuring compliance and patient safety in Switzerland.

By partnering with Qarad Suisse SA, you benefit from:

Local expertise in Swiss regulations (MedDO & IvDO) supported by extensive MDR/IVDR experience.
Trusted regulatory interface with Swissmedic, ensuring requirements are handled correctly and without delays.
Established presence with a valid CHRN, with mandates duly registered.
Structured vigilance processes for fast, compliant incident reporting and trend submissions.
Continuity across regions, with Qarad also serving as EU Authorised Representative, UK Responsible Person (UKRP), and CH-REP.

With Qarad Suisse SA, you meet more than a legal requirement; you gain a reliable Swiss partner who ensures compliance, facilitates communication, and supports your long-term success in the Swiss market.

Contact Qarad Suisse SA to ensure a smooth and compliant entry into the Swiss market.

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