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Swiss Authorized Representative (CH-REP)

Swiss Authorized Representative (CH-REP)

The device’s market placement requires the manufacturer to designate an authorized representative in Switzerland through a written mandate, if the manufacturer is not Swiss-based.

Role of an Authorized Representative

The authorized representative is responsible for the formal and safety-related aspects of introducing a device to the market.

Verify Conformity: Confirm the EU declaration of conformity and technical documentation are in order and that the manufacturer has completed the necessary conformity assessment.

Maintain Documentation: Keep a copy of technical documentation, the EU declaration of conformity, and relevant certificates for authorities as per legal requirements.

Fulfill Registration Obligations: Ensure the manufacturer meets registration requirements under Articles 27, 29, and 31.

Provide Information to Authorities: Share information and documentation proving device conformity upon request, using the language required by the Member State.

Forward Requests: Relay requests from authorities to the manufacturer and ensure authorities receive necessary samples or access to devices.

Collaborate on Safety Measures: Work with authorities on preventive or corrective actions to manage device risks.

Report Issues to Manufacturer: Promptly inform the manufacturer about complaints and reports regarding potential device issues.

Terminate Mandate for Non-Compliance: End the mandate if the manufacturer fails to meet regulatory obligations.