An EU-authorised representative is a natural or legal person expressly designated by a manufacturer located outside the EEA (including the EU and EFTA) as an EU-Representative, i.e. an EU-authorised representative, also known as an EU-representative. This natural or legal person can perform on behalf of a manufacturer outside the EEA the specific duties required of the manufacturer by the relevant EU directives and laws.

Medical Device ISO 14971 Risk Management Training Services.