European Authorized Representative

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.

Overview

Regulation of goods produced by manufactures outside of the European Union, especially in the medical devices industry, instigated the need for Authorised 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 Authorised Representative. As stated in this amendment, an Authorised 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 a European Authorised Representative

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.

gollark: There we go.
gollark: It is very irritating that postgres doesn't support TF-IDF at all. Even SQLite has this.
gollark: Now to actually make the search bit work.
gollark: Using exponential regression, I determine that I'll have the whole internet downloaded within about 10 hours.
gollark: Wow, 32 domains found just crawling osmarks.net!

See also

References

GUIDELINE FOR AUTHORISED REPRESENTATIVES

http://ec.europa.eu/health/medical-devices/files/meddev/2_5_10_ol_en.pdf

This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.