Special Report: The ROLE a of European Authorized Representative by Miguel Ohn (Obelis European Authorized Representative Center Project Manager)
The 93/42/EEC Article 14 and the 98/79/EC Article 10 of the European Directives which regulate medical/in vitro devices in the European Market says:
Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a European Member state, he shall designate the person(s) responsible for marketing the product who is (are) established in the Community. These persons shall inform the competent authorities of the Member State in which they have their registered place of business of the address of the registered place of business and the category of devices concerned.
This means, a manufacturer located outside the European Union which do not have place of business in the European Community must appoint European Authorized Representative to sell his/her product in the EU territory.
The European Authorized Representative is an entity established within the European Community or in a State which is a party to an Association Agreement who, explicitly designated by the manufacturer, acts for the manufacturer and may be addressed by the authorities and bodies in the European Community instead of the manufacturer.
The appointed European Authorized Representative should:
1. Notify your product to the Competent Authority in order to apply for CE Marking, if your product falls into following category.
-CLASS I : non sterile devices
-CLASS I : sterile & measuring function device
-Self Certification Products
-SELF TESTING, ANNEX II or PERFORMANCE EVALUATION Products
2. Provide a European Business Address as required by the Directive.
Labeling & Instruction of use
MDD 93/42/ECC Article 4.4
MDD 93/42/ECC Annex I § 13.3
IVD 98/79/EC Annex I § 8
3. Keep the technical documentation, including the declaration of conformity, for routine inspection by the European Competent Authorities, for a period ending at least five years after the last product has been manufactured.
4. Ensure the communications issued by the European Competent Authorities reach the manufacturer as well as the communication issued by the manufacturer to reach the European Competent Authorities.
5. Observe the manufacturer's compliance with the conformity assessment procedure set out in the European Directive which applies to the product.
EC Declaration of Conformity and contents of Technical File
MDD 93/42/ECC Annex VIII
IVD 98/79/EC Annex III
Obelis (O.E.A.R.C.) provides superior quality "European Authorized Representative Services" with fully integrated business solutions to assist you in your venture to Europe and/or the United States. Obelis (O.E.A.R.C.) is backed by 16 years, giving Commercial, Regulatory, Administration, and Market Development services.
For more information visit our website: www.obelis.net
MEDICA Hall 17 D58