Authorised Representative

According to the Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR), an EU Authorised Representative (EU AR) needs to be designated by all medical device or in vitro diagnostic manufacturers based outside the EU that wish to sell their products in any of the Member States (MDR/IVDR Article 11).

Evnia Authorized Representative

Representation requirements

EU representation is a requirement for all manufacturers established outside the EU, without any physical presence (i.e., address) in an EU country.


Person responsible for regulatory compliance

A Person Responsible for Regulatory Requirements (PRRC) is required by the Medical Device Regulation 2017/745 (MDR, Article 15.6) and In vitro Medical Device Regulations 2017/746 (IVDR, Article 15.6) for EU Authorised Representative (EUAR).

Person Responsible for Regulatory Requirements (PRRC)


EUDAMED (European Database on Medical Devices) is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro medical devices, created to improve transparency and coordination of information regarding medical devices available on the EU market.


UK – representation

For your UK – representation needs, please visit our UK- Responsible Person dedicated service.

Contact Us

Get In Touch

Phone Number

0045 3274 5397

Email Address



Inge Lehmanns Gade 10 8000, Aarhus C