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Saturday, July 3, 2010

Authorised Representative

As of 21 March 2010, a Single EU/EC European Authorised Representative (Authorized Representative) must be designated by a non-EU manufacturer of medical devices as required by Article 14.2* of Council Directive 93/42/EEC amended by Directive 2007/47/EC.

EC Rep: what is a European (EU/EC) Authorised Representative (Authorized Representative)?

An (EU/EC) European Authorised Representative (also called Authorized Representative) is a natural or legal person established in the EU who, explicitly designated by a non-Euroepan manufacturer, acts on his behalf in carrying out certain tasks required in the applicable directives.

  • For the purposes of New Approach directives the Authorised/Authorized Representative must be established inside the Community.

  • The Authorised/Authorized Representative may be addressed by authorities and bodies in the EEA Member States instead of the manufacturer with regard to the latter’s obligations under the New Approach Directives.

  • Commercial representatives of the manufacturer (such as importer, authorized/authorised agent, authorized/authorised distributor), whether or not established inside the Community, are not to be confused with the Authorised/Authorized Representative in the meaning of New Approach directives.

  • The manufacturer remains generally responsible for actions carried out by an Authorised/Authorized Representative on his behalf.
The delegation of tasks from the manufacturer to the Authorised/Authorized Representative must be explicit and should take place in writing, in particular to define the contents of the tasks and the limits of the representative’s powers. The tasks that may be delegated to the Authorised/Authorized Representative according to the directives are of an administrative nature. Thus, the manufacturer may neither delegate the measures necessary to ensure that the manufacturing process assures compliance of the products nor the setting up of a technical documentation, unless otherwise provided for. Further, an EU/EC Authorised/Authorized Representative cannot modify the product on his own initiative in order to bring it into line with the applicable directives.

    *Article 14.2 of Council Directive 93/42/EEC as amended by Directive 2007/47/EC:
    Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.


FAQ/Q&A: Questions and Answers about CE Marking of Medical Devices


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