Regulatory Background

The concept of an Authorized Representative is based on legal requirements of the European Directives 93/42/EEC (the MDD), 98/79/EC (the IVDD) and 90/385/EEC (the AIMDD) for non-European Manufacturers.
The Authorised Representative within the European Union (EU) may assume certain responsibilities on behalf of the manufacturer if delegated by the manufacturer. The legal definitions of Manufacturer and Authorised Representative are given in the Directives, as follows.

Manufacturer :

Manufacturer means the natural or legal person with responsibility for the design, manufacturing, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party (MDD 93/42/EEC-Article 1.2.(f) and- IVDD98/79/EC-Article 1.2.(f)).

Authorized Representative :

Authorised Representative means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive.

  • Please click here to download the European Directive 93/42/EEC (Medical Devices Directive – MDD)
  • Please click here to download the European Directive 98/79/EC (In-Vitro Diagnostics Directive – IVDD)
  • Please click here to download the European Directive 90/385/EEC (Active Implantable Medical Devices Directive – AIMDD)