authorized representative

any natural or legal person established within a country or jurisdiction who has received a mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter's obligations under that country's or jurisdiction's legislation

Note 1

In the European Union, Directive 98/79/EC ^[38] requires the manufacturer to designate an “EC authorized representative”, established in the European Community if the manufacturer is not located in the European Community.

Note 2

Adapted from Reference [39].

Norm

NEN-EN-ISO 18113-1:2011 en

Titel

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

Paragraaf

3.4

authorized representative

Gerelateerde termen