To place medical devices on the Swiss market, manufacturers established outside Switzerland and Liechtenstein must fulfil defined regulatory requirements under the Swiss Medical Devices Ordinance (MedDO).

Key obligations include:

• Appointing the CH-REP through a formal written mandate in accordance with Article 51 MedDO
• Completing the applicable conformity assessment procedures
• Ensuring compliant device labelling, including identification of all relevant economic operators
• Registering economic operators and devices in Swissdamed
• Implementing post-market surveillance and vigilance processes, including reporting obligations to Swissmedic

A structured onboarding process with a qualified CH-REP supports regulatory compliance, legal certainty, and efficient market access in Switzerland.

The CH-REP acts as the manufacturer’s regulatory interface within Switzerland and performs the tasks assigned under Article 51 MedDO throughout the lifecycle of the medical device.

Key obligations include:

• Verifying that required regulatory documentation has been established and is available
• Acting as the official point of contact for Swissmedic
• Supporting registration activities and updates in Swissdamed
• Cooperating with the manufacturer in post-market surveillance, vigilance, and field safety corrective actions (FSCA)
• Assessing the regulatory implications of product changes

The CH-REP function is not limited to initial market access but constitutes an ongoing regulatory role within the defined legal framework.

For devices already compliant with MDR requirements, the CH-REP must be indicated on the device label. For higher-risk devices (Class > I) still subject to the transitional provisions under Article 120 MDR, the CH-REP may be identified on the label, in the Instructions for Use, or on an accompanying document. The importer may be indicated on the device, packaging, or an accompanying document, irrespective of device classification.

Pursuant to Article 16 MedDO, product information must be provided in Switzerland’s three official languages: German, French, and Italian. Symbols defined by technical standards may replace textual elements. Product information may be limited to fewer official languages or English if the conditions set out in Article 16(3) a.–d. are fulfilled.

Pursuant to Article 16 MedDO, product information requirements follow Annex I, Chapter III of the EU MDR. Product documentation must generally include labelling and the Instructions for Use (IFU), providing all information necessary for the safe and intended use of the device.

No. Siotec AG acts exclusively as a CH-REP in accordance with Article 51 MedDO, aligned with Article 11 EU MDR. It does not assume importer or distributor roles.

Yes. A manufacturer may designate different CH-REPs for distinct product groups or families. Each CH-REP must have a separate written mandate defining their responsibilities.

No. Although it is commonly considered best practice, inclusion is not required. Siotec AG maintains comprehensive liability coverage, ensuring that the manufacturer is not obligated to list the CH-REP as an additional insured party.

Yes, any changes to device design, labelling, intended purpose, or Technical Documentation must be promptly communicated to the CH-REP. The CH-REP assesses the regulatory impact, updates registrations in Swissdamed if required, and ensures compliance with MedDO, including post-market surveillance and vigilance obligations.