SAR Swiss Authorized Representative Service

According to Swiss MedDo Article 51, the Swiss Authorized Representative should support Manufacturer in the following:

  • Prove compliance with the registration obligations in Switzerland as per the revised MedDo.
  • Prove compliance with MedDo’s device labeling requirements
  • Giving access of the medical device’s samples to the Competent Authority.
  • Cooperating with the Competent Authority to take any preventive or corrective action.
  • Informing the manufacturer about complaints from patients, users, and healthcare professionals.
  • Ensuring that Technical Documentation, EU Declaration of Conformity, and a relevant certificate is available for authority review
  • Demonstrating device’s conformity by providing all the necessary documentation and information upon Competent Authority’s request.

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It is challenging job for companies to arrange and liaison with three different entities to comply with the requirement in these territories. Appointing TS Q&E, the requirement for having three different authorized representatives can be managed under one umbrella.
TS Q&E can offer support for manufacturers to appoint Authorized Representatives in Europe, Switzerland and UK.