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What Is Why Need Difference Why Wellkang Questions & Answers FREE guide on CE marking of medical devices MDD/IVDD
medical devices EU/EC European Authorised/Authorized Representative

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Wellkang is a registered EU Authorised Representative (EC Rep) in the European Commission's EU medical device database EUDAMED under a unique Single Registration Number (SRN): XI-AR-000001836 for the markets of EEA/EU27 & Northern Ireland.

Wellkang is also a registered UK Responsible Person (UKRP) in the UK MHRA medical device database for the market of Great Britain: England, Wales & Scotland, after 1 Jan 2021, which is no longer part of the EU single market after Brexit.

Are you ready for Brexit impacts? Do you have a Brexit contingency plan?

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

Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical
Devices with MHRA in UK & other EEA (EU/EFTA) authorities by world-leading
consultancy- Wellkang team based in both UK (England) & EU-27 (Ireland).

Wellkang team can help you under all 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, so-called "UK Responsible Person", 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) (EC Rep) 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.

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

An (EEA/EU/EC, UK) European Authorised Representative (also called Authorized Representative) is a natural or legal person established in the European Economic Area (EEA, including EU & EFTA) or United Kingdom (UK), who, explicitly designated by a non-European 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 Member State in which he has his registered place of business of the details referred to in paragraph 1.
UK Rep: what is a UK Responsible Person (commonly known as UK Authorised Representative (Authorized Representative)) ?

A UK Authorised Representative (Authorized Representative) (officially so-called "UK Responsible Person") means a person (natural or legal person) established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the (non-UK) manufacturer’s obligations under UK regulations.

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.

For the purposes of CE Marking conformity and single market or UK market, references to EU countries should be read as references also to EEA states (incl. Iceland, Liechtenstein and Norway).


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