What is a European Authorized Representative?
Non-European manufacturer of medical devices
must designate an European Authorized Representative
in order to meet certain requirements under the European Medical Directives:
- Medical Device Directive (MDD) 93/42/EEC - article14, point 2
- Active lmplantable Medical Device Directive (AIMDD) 90/385/EEC - article10, point 3
- In Vitro Diagnostic Medical Device Directive (IVD) 98/79/EC - article 10(a), point 2
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The Manufacturer is required to provide access to the technical documentation and to attach his Authorized Representative’s address to the description of the product. Manufacturer of Medical Devices and the Authorized Representative must understand and take a note of the representative’s duties and responsibilities BEFORE they assign the agreement. |
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EC/EU Authorized Representative
is the primary contact point for the European Commission and the National Competent Authorities. |
TASKS AND RESPONSIBILITIES OF AUTHORIZED REPRESENTATIVE
MUST BE LISTED IN WRITTEN FORM (official written contract).
Manufacturer sales representatives (such as importers, authorized sales, authorized distributor) should not be confused with the Authorized Representative within the meaning of New Approach directives.
