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.
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.
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.
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
About CE Marking: