EU Auth. Representative

The appointment of an EU Authorised Representative (EC REP) is mandatory for all medical device manufacturers outside the EU who wish to sell and place on the medical and in-vitro devices market in the EU.

BioReg cooperates with EC REP, who possess the necessary expert knowledge on regulatory requirements for medical devices. This knowledge is supported by academic qualifications and professional experience in regulatory affairs and quality management relating to medical devices.
For more information, please contact the BioReg team.