How to Choose a Swiss Authorised Representative (CH-REP)
If your company is based outside Switzerland and you want to place medical devices or IVDs on the Swiss market, you need a Swiss Authorised Representative (CH-REP). Under Art. 51 of the Swiss Medical Devices Ordinance (MedDO), a manufacturer without a registered office in Switzerland may only place a device on the market after appointing a CH-REP based in Switzerland under a written mandate. The same applies to IVDs under the IvDO. An EU Authorised Representative does not replace the CH-REP.
Many providers offer this role, from large global consultancies to small Swiss specialists. This guide lists the points that matter most when you compare them.
1. A Swiss address and a registered actor
The CH-REP must be established in Switzerland. Its name and address appear on your labelling, so the address must allow Swissmedic and users to contact the representative. According to Swissmedic, a P.O. box, an e-mail address or a phone number alone is not enough.
Authorised representatives must register with Swissmedic before devices are placed on the market and receive a Swiss registration number (CHRN). Ask the provider for its Swiss company details and its CHRN.
2. Experience with your device classes
Check that the provider handles your type of product: Class I to III medical devices, IVDs, or both. Ask how many mandates in your area it currently holds and whether it has dealt with Swissmedic requests for products like yours.
3. A clear written mandate
The rights and duties of the CH-REP follow Art. 11 of the EU MDR, to which the MedDO refers. A good mandate states clearly:
- which documents the CH-REP keeps or can obtain (technical documentation, Declaration of Conformity),
- how incidents and field safety corrective actions are handled,
- how Swissmedic requests are answered and within what time,
- how the mandate can be ended or transferred.
The MedDO also allows the manufacturer and CH-REP to agree that the manufacturer sends the technical documentation directly to Swissmedic on request. In that case the CH-REP must make sure it arrives within seven days. Ask whether the provider offers this option.
4. Labelling support
Your devices must show the CH-REP's name and address, either next to the CH-REP symbol or with a text such as "CH-REP". A good provider tells you exactly what to print and checks your labels and IFU before you go live. Read more in our post CH-REP Symbol and Labelling.
5. swissdamed registration
Since 1 July 2026, devices must be registered in the Swiss database swissdamed before they are made available in Switzerland. Devices that were already on the market before that date have until 31 December 2026. Details and fees: swissdamed Registration Fees 2026. Ask whether the CH-REP registers your devices for you, what data it needs from you and whether this is included in the fee.
6. Do you also need a Swiss importer?
The company in Switzerland that places your device on the Swiss market from abroad is the importer (CH-Importer), with its own obligations. If a Swiss distributor already takes on this role, the CH-REP mandate may be enough. If not, for example because you sell directly to hospitals or practices, you need a Swiss importer. Having CH-REP and CH-Importer with one provider means one contact and one contract. See CH-Importer and Responsibilities of the CH-Importer.
7. Transparent costs
Prices differ widely. Some providers charge a fixed monthly or annual fee, others charge per device, per registration or per hour. Ask for a written quote that shows:
- the base fee,
- what is included (labelling check, swissdamed, vigilance support),
- what costs extra,
- notice periods.
8. Response time and language
Swissmedic requests and incidents have deadlines. Ask how quickly the provider answers and in which languages. A CH-REP that answers in your language saves time when documents need to be explained.
Switching your CH-REP
You can change your CH-REP. Under Art. 51 para. 4 MedDO, the change follows the rules of Art. 12 EU MDR: the old and new representative and the manufacturer agree on the date of the change and on how labelling, documents and ongoing cases are handed over. Plan enough time to update your labels.
Quick checklist
- Swiss address and CHRN confirmed
- Experience with your device classes and IVDs
- Written mandate with clear duties and exit rules
- Labelling and swissdamed support defined
- CH-Importer role clarified
- Written quote with all costs
- Agreed response time and language
FAQ
Can my EU Authorised Representative also act as CH-REP?
Only if it has a legal entity in Switzerland and is registered as CH-REP. An EU address is not accepted for the Swiss role.
Do I need a CH-REP for Class I devices?
Yes. The requirement applies to all device classes and to IVDs when the manufacturer is based outside Switzerland.
Can the CH-REP and the importer be the same company?
Yes. Many manufacturers choose one provider for both roles.
Need a Swiss Authorised Representative?
CHREP.me GmbH in Zug acts as Swiss Authorised Representative (CH-REP) and Swiss Importer (CH-Importer) for manufacturers of medical devices and IVDs outside Switzerland. One contact for both roles, fixed monthly fees and answers in English or German.
