EU Authorised Representative (EUAR) Service

EU Authorised Representative (EUAR) Services for Non-EU Medical Device Manufacturers

Entering the EU medical device market can be complex, especially for companies operating outside the European Union. We support non-EU manufacturers by acting as their EU Authorised Representative (EUAR), ensuring full compliance with EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements.

Our team manages every step of your regulatory journey, including:

• EUDAMED registration of manufacturers, devices, and relevant economic operators

• Regulatory documentation review to confirm MDR/IVDR conformity

• Communication with EU Competent Authorities on your behalf

• Risk Management and Post-Market Surveillance plans i

• Ongoing regulatory guidance to ensure your devices remain compliant throughout their lifecycle

With our support, non-EU companies gain a trusted partner who ensures a smooth, efficient, and fully compliant entry into the European market. We enable you to focus on innovation and commercial growth while we handle the regulatory responsibilities required within the EU.