Overview
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
Challenges
- 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
Solution
- 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
