Regulatory Background

The concept of an Authorized Representative is based on legal requirements of the European Directives 93/42/EEC (the MDD) and 98/79/EC (the IVDD) for non-European Manufacturers.

The Authorized Representative assumes certain responsibilities on behalf of the Manufacturer within the European Union. The legal definitions of the Manufacturer and the Authorized Representative given in the Directives define the role of the Authorized Representative.

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:
Authorized 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 (MDD-93/42/EEC Article 1.2.(j).and – IVDD 98/79/EC-Article 1.2.(g)).

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