European Authorized Representative

European Authorized Representative

A European Authorized Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives.


Regulation of goods produced by manufactures outside of the European Union, especially in the medical devices industry, instigated the need for Authorized Representatives. As clarified in the Medical Devices Directive amendment (93/42/EEC), it is required that alongside the CE mark all products must also have an Authorized Representative. As stated in this amendment, an Authorized Representative should serve as a contact point with the EU member states competent authorities.

An E.A.R. holds the responsibility to act as a neutral party between the competent authorities and the non EU manufacturers. They must ensure the manufacturer’s compliance with the conformity assessment procedure set out in the European directives which apply to the manufacture’s product. The EAR must uphold dual accountability with the manufactures if problems or questions arise regarding the product. The E.A.R. must provide their contact information for the manufacturer to place on the products, allowing the E.A.R. to be the primary contact for EU authorities.

Duties of an European Authorized Representative

An E.A.R. observes the manufacturer's compliance with the conformity assessment procedure set out in the European directives which apply to the product.

They ensure the law is met by having Class I medical devices registered with the competent authorities before being placed on the market.

They ensure their contact information is available to the manufactures to be placed on all the products they are representing, thus acting as a primary contact for the EU Authorities.

They must notify EU Authorities of all major incidents pertaining to products.

An E.A.R. must understand all EU regulations from each of the twenty seven EU member states as well as the four European Free Trade Association (EFTA) states, and provide notification of changes and amendments to directives that affect individual products.

They must keep the product’s technical file available at any time for the EU member states authorities and maintain confidentiality with manufacturer's sensitive product information, releasing them only to the appropriate authorities when called upon.

See Also

CE Mark
Directive (European Union)
European Union Legal System
Regulation (European Union)
List of EU Directives
Medical Devices Directive


1) Ohn, Miguel. 2008. "Appointing a European Authorized Representative"4) Ohn, Miguel. "The Role of Non-European Manufacturers"5) Dr. Peter N. Ruys, one of the initial writers of the Medical Device Directive and Regulatory Advisor for Obelis s.a.6) Authorized Representative for producers and exporters

External Links

[] [] [] []
[Category:Legal terms]

Wikimedia Foundation. 2010.

Игры ⚽ Нужен реферат?

Look at other dictionaries:

  • European National Front — is a coordinating structure of European far right extremist, Third Positionist, anticommunist and nationalist parties. Sometimes members of the EAL use anti capitalist rhetoric, too. Structure General Secretary The European National Front is… …   Wikipedia

  • European Medicines Agency — European Medicines Agency …   Wikipedia

  • European Union — 1. an association of European nations formed in 1993 for the purpose of achieving political and economic integration. Formerly known as the European Economic Community, the European Union s member states are Austria, Belgium, Denmark, Finland,… …   Universalium

  • European Central Bank — European Central Bank …   Wikipedia

  • Italian Device Registration — The Italian Ministry of Health (MOH) has implemented mandatory procedures for the Italian Registration of Medical Devices as of May 1st, 2007. Overview Placing a Medical Device into the European market is contingent upon compliance with the… …   Wikipedia

  • Clinical trial — Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be… …   Wikipedia

  • CE mark — The CE marking CE marking (originally EC mark[1]) is a mandatory conformity mark for products placed on the market in the European Economic Area (EEA). With the CE marking on a product the manufacturer ensures that the product conforms with the… …   Wikipedia

  • Controlled Substances Act — Acronym CSA Enacted by the 91st United States Congress Effective October 27, 1970 Citations Public La …   Wikipedia

  • PHILANTHROPY — Introduction At the close of the 18th century the communal system of fund raising for charity with authority vested in the charity overseers (Gabba ei Ẓedakah) – to tax members of the community in order to ensure appropriate giving – was on the… …   Encyclopedia of Judaism

  • Cherokee — For other uses, see Cherokee (disambiguation). Cherokee ᏣᎳᎩ ᎠᏂᏴᏫᏯᎢ …   Wikipedia

Share the article and excerpts

Direct link
Do a right-click on the link above
and select “Copy Link”