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medical devices EU/EC European Authorised/Authorized Representative

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You may need either an EU/EC European authorized representative based in EU-27 countries or a UK Authorised Representative based in UK, or may need both EU & UK representatives, depending on different brexit scenarios.

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After 29 March 2019 if there’s no Brexit deal between UK & EU, i.e. under a cliff-edge hard Brexit, you may need to appoint both an EU (EEA/EC) Authorized Representative (EC Rep), based in EU27 or EEA, and a UK Authorised Representative (UK Rep), based in the United Kingdom, if you place products on both UK or EU27/EEA markets! You MUST have a Brexit contingency plan if you place products on either UK or EU27/EEA markets! Wellkang team can help you under all Brexit scenarios! Click here to get FREE Guide Now!

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

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

An (EEA/EU/EC) European Authorised Representative (also called Authorized Representative) is a natural or legal person established in the EEA 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 EEA/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 Economic Area (EEA). For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the EEA Member State in which he has his registered place of business of the details referred to in paragraph 1.

The European Economic Area (EEA):

The EEA includes EU countries and also Iceland, Liechtenstein and Norway. It allows them to be part of the EEA single market.

Switzerland is neither an EU nor EEA member but is part of the single market.

UK Rep: what is a UK Authorised Representative (Authorized Representative)?

A UK Authorised Representative (Authorized Representative) is a natural or legal person, recognised under UK law and established in The United Kingdom (UK- officially the United Kingdom of Great Britain and Northern Ireland), appointed by a non-UK manufacturer to carry out certain tasks on the non-UK manufacturer’s behalf under UK law in relation to manufactured goods.


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