Gate to EU — EU market entry for medical devices
Path for non-EU manufacturers (USA, UK, Turkey and others): AR / importer role mapping, EUDAMED, initial documentation and practical next steps. Quote after an initial consultation.
€3,000–8,000range · quote after an initial consultation
2–8 weeksdepends on scope
Prices in EUR, excluding VAT. VAT treatment will be specified in the individual proposal.
Opens your email app. The initial 20-min consultation is free.
When this service helps
- Non-EU manufacturers without EU RA capacity
- USA / UK / Turkey companies planning first EU sales
- Teams needing an economic operator role map
Inputs and scope boundaries
- The service does not include taking on the manufacturer role.
- CE certification and notified body audits fall outside the scope.
- AZ Regulatory does not act as the Authorized Representative under this service.
Typical scope
- Economic operator role map (AR, importer, distributor)
- Entry plan: EUDAMED, initial documentation, URPL orientation
- Data preparation support and checklists
- Contract / responsibility recommendations (not a law firm substitute)
The service covers mapping AR and importer roles, not acting as the AR.
Planning EU market entry?
Brief us on the device and manufacturer country — reply within 3 business days.
Discuss this service by emailAdvisory and documentation service. We are not a notified body. The service does not include acting as the Authorized Representative (AR). No guarantee of CE certification or registration outcome.