CH-REP Services

Definition of Swiss Authorized Representative (CH-REP)

A CH-REP is a legal entity established in Switzerland that has been formally appointed by a manufacturer based outside Switzerland or Liechtenstein through a written mandate. In this capacity, the CH-REP performs defined regulatory tasks on behalf of the manufacturer in relation to the placing of medical devices on the Swiss market and acts as an interface with Swissmedic for relevant regulatory matters.

Pursuant to Article 51 MedDO, manufacturers established outside Switzerland and Liechtenstein may place medical devices on the Swiss market only if they have designated a CH-REP. This requirement applies equally to manufacturers established in the European Union or any other third country.

The written mandate defines the scope of the CH-REP’s responsibilities and ensures alignment with applicable Swiss regulatory requirements.

CH-REP Duties under the Swiss Medical Devices Ordinance (MedDO)

The CH-REP performs legally defined regulatory tasks and forms part of the manufacturer’s regulatory framework. These duties are governed by Article 51 MedDO, with reference to Article 11 EU MDR.

The CH-REP verifies that the manufacturer has fulfilled the applicable regulatory requirements and that the required documentation is available.

Key obligations include:

• Verification of conformity documentation: Verifying that the applicable conformity assessment procedures have been carried out by the manufacturer and that the EU Declaration of Conformity has been issued
• Availability of technical documentation: Ensuring that the technical documentation can be made available to Swissmedic upon request
• Regulatory point of contact: Acting as the official contact for Swiss authorities and cooperating in the context of market surveillance activities
• Vigilance cooperation: Cooperating with the manufacturer to support the reporting of serious incidents and field safety corrective actions (FSCA) in accordance with applicable requirements
• Lifecycle support: Supporting the manufacturer in maintaining regulatory compliance throughout the device lifecycle

Obligations for Non-Swiss Manufacturers

Manufacturers established outside Switzerland and Liechtenstein are subject to defined regulatory obligations prior to placing medical devices on the Swiss market under the MedDO.

Key obligations include:

• Appointment of a CH-REP in accordance with Article 51 MedDO via a written mandate
• Ensuring compliant device labelling, including identification of the CH-REP and other economic operators
• Ensuring that technical documentation has been established and is maintained
• Compliance with Swiss registration requirements (Swissdamed)
• Implementation of post-market surveillance and vigilance processes

Differentiation of Economic Operator Roles

The MedDO clearly distinguishes between different categories of economic operators, each with legally defined responsibilities to ensure regulatory compliance, traceability, and effective market surveillance.

Key economic operator roles under MedDO include:

• Manufacturer (Article 4 para. 1 let. f MedDO): Responsible for the design, manufacture, conformity assessment, and overall regulatory compliance of the medical device.
• Swiss Authorized Representative (CH-REP) (Article 4 para. 1 let. g MedDO): Acts on behalf of the manufacturer in all regulatory matters within Switzerland, ensuring adherence to MedDO requirements.
• Importer (Article 4 para. 1 let. h MedDO): Legally responsible for placing medical devices originating from abroad onto the Swiss market.
• Distributor (Article 4 para. 1 let. i MedDO): Ensures devices are made available within the Swiss supply chain and maintains traceability throughout distribution.

Each role is established either by formal designation (e.g., CH-REP) or by the nature of the activity performed (e.g., importer).

CH-REP Mandate Process

The CH-REP mandate is structured, risk-based, and designed to ensure full regulatory compliance for manufacturers entering the Swiss market.

Key steps include:

• Review of Technical Documentation and certificates: Ensuring completeness, accuracy, and compliance with Swiss regulatory requirements.
• Verification of conformity assessment procedures: Confirming that all applicable conformity assessment processes have been correctly performed.
• Assessment of labelling and regulatory compliance: Verifying that device labelling, instructions for use, and economic operator information meet MedDO standards.
• Mandate setup: Establishing a formal written mandate between the manufacturer and CH-REP, defining the scope of responsibilities in accordance with Article 51 MedDO.
• Registration of economic operators where required: Ensuring that all economic operators are properly registered in Swissdamed.
• Establishment of communication processes with authorities: Setting up efficient channels for reporting, incident management, and interactions with Swissmedic.

The duration of the onboarding process depends on the completeness and quality of the documentation provided by the manufacturer.