AZ RegBridge

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 kick-off.

€3,000–8,000range · quote after kick-off

2–8 weeksdepends on scope

Free 20-min consultation WhatsApp

Who it is for

Non-EU manufacturers without EU RA capacity
USA / UK / Turkey companies planning first EU sales
Teams needing an economic operator role map

Who it is not for

“You become the manufacturer for us”
All-in CE / notified body packages
Assuming we automatically act as AR

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)

AR and importer are separate entities and contracts — we are not an automatic AR.

Planning EU market entry?

Brief us on the device and manufacturer country — reply within 3 business days.

Email us

Advisory and documentation service. Not a notified body or automatic Authorized Representative. No guarantee of CE certification or registration outcome.