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.
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.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.
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