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EAR Services for Switzerland-based
Medical Device Manufacturer


Project Background

  • Customer –A Switzerland-based manufacturer specializing in dermatology, plastic surgery, burns, wounds, and scar management
  • Device Category - Skin treatment gels
  • Service Offering - European Authorized Representation (EAR) Services
  • Health Authority – BfArM

Business Imperatives

  • The customer is a well-established player in the Switzerland market
  • The customer has Class I and Class IIa products to be sold in the EU countries
  • The customer had the privilege of single market access before the SWIXIT situation (the expiration of the Mutual Recognition Agreement [MRA])
  • Post to non-renewal of MRA (SWIXIT), the Switzerland-based medical device manufacturer, is regarded as a foreign manufacturer in the European Union
  • The customer required an EAR to place their product in the EU countries


  • Change in Point of Contact (PoC) of the manufacturer
  • No clarity about the requirements and the process flow from the PoC’s perspective

Client Benefit Highlights

  • Freyr is a registered EAR with EUDAMED
  • Freyr has all the necessary QMS in place required to act as an EAR
  • Cost-effective EAR service
  • Annual reports


  • The customer appointed Freyr as an EAR
  • Helped in Actor module registration of the manufacturer in the EUDAMED portal
  • Supported the customer and their PoC to understand the Regulatory process in the EU and the functions of an EAR
  • Apart from being an EAR, Freyr was also the PoC between the manufacturer & competent authority and helped through the submission of the application until the registration certificate was issued
  • As an EAR, Freyr's name, address, and phone number were used on labels