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What is European Authorized Representative (E.A.R) ?

A European Authorised 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 & Regualtions.

Why do you need European Authorized Representative (E.A.R) ?

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.

What are European Authorized Representative (E.A.R) accountabilities ?

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.

What are the duties of an European Authorized Representative (E.A.R) ?

An E.A.R. observes the manufacturers' 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 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.

Most customers request us to be their EAR for the following European regulations / Directives (not limited to) 

Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)

Council Directive 93/42/EEC on Medical Devices (MDD) (1993)

Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVDMD) (1998)

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

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