EU Authorised Representative (EUAR)

An EUAR is a designated entity that acts on behalf of non-EU-based MedTech manufacturers to ensure compliance with European medical device regulations.

An EUAR is essential to meet regulatory requirements, facilitate market access, and serve as a point of contact with European authorities for non-EU manufacturers.

Some of the main responsibilities of working as an EUAR include representing you as the manufacturer, maintaining technical documentation, assisting with regulatory compliance and acting as your point of contact for EU authorities.

As an approved EUAR on EUDAMED, our team at Apotech has substantial expertise in regulatory compliance and can act as your designated representative in the EU to seamlessly communicate with EU authorities on your behalf.

EUDAMED SRN NUMBER: FR-AR-000039455

Yes, for micro-manufacturers and small companies, it is possible to outsource the PRRC role to an outside expert. The micro or small enterprise may subcontract the responsibilities of a person responsible for regulatory compliance to a third party, so long as the qualification criteria are met and the manufacturer can demonstrate and document how they can meet their legal obligations.

Yes, our team can also act as your authorised representative if you work in the cosmetics industry.

Registered with both the European Commission and MHRA, we can notify your cosmetic products on the relevant portal, whether that be the CPNP or SCPN portal. Acting under a legal mandate, we would review your product information file, control the relevant labelling, notify the target market (EU or UK) and endorse the responsibility of the responsible person.