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Authorized Representative Responsibilities

Definition (MD and IVD Directives) and Main Responsibilities

« Authorized Representative means any natural or legal person established in the Community who, explicitly designated by the Manufacturer, acts and may be addressed by Authorities and Bodies in the Community instead of the Manufacturer with regard to the latter’s obligations under this directive ».

In fact, the Authorized Representative is the European legal existence of a Manufacturer without official European subsidiary. The Authorized Representative is responsible before the national competent Authorities and the European Commission as these Authorities will not communicate directly with companies whose registered place of business is located outside the EU. The address of the Authorized Representative is printed on the label, the instructions for use or the outer packaging.

The Authorized Representative acts on behalf of the Manufacturer and for that reason is in permanent relation with him, with its distributors and with the European Competent Authorities for the product notifications, Incident analysis, Incident Reporting and voluntary Product Recall. In case of a risk of product withdrawal by the Competent Authorities, the Authorized Representative should be able to negotiate at the highest level with the Authorities and send, in agreement with the Manufacturer, the right answers for report, in accordance with the European regulation, with protection of the patients and of manufacturer’s interest.

The Authorized Representative keeps available for consultation by Authorities an updated copy of the part A of the Technical File and of the register of European product complaints. For that reason the highest level of confidentiality is requested and is formalized in the contract or by a separate written agreement.

Taking in account the responsibilities, the civil liability insurance of the Manufacturer shall cover Authorized Representative for corporal, material and immaterial risks.

The high competency in European Regulatory Affairs, very good knowledge of medical devices and hospital environment, and respectable relationship with European and National competent Authorities are necessary to fulfil the responsibility of Authorized Representative.

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