European agent (Authorized Representative) is a natural or legal person within EC region, expressly appointed by a manufacturer, who acts on behalf of a manufacturer regarding obligations of the manufacturer under this guideline and contact with authorities and certification services within EC.

According to the guideline for European agent (GUIDELINE FOR AUTHORISED REPRESENTATIVES – MEDDEV 2.5/10), responsibility of a manufacturer does not change, but selection of the European agent must be accurately assigned and monitored by the manufacturer.

The European agent does not simply act as a contact point for matters incurred from Europe on behalf of manufacturers of medical devices in countries other than Europe, however, the agent is obligated to receive information from the manufacturer regarding registration of medical device products in the European agent’s country and management of history of sales in the European medical device market.

According to the medical device law published in September, 2012 (Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009), the European agent is required to have at least one experienced person within the company who has specialized knowledge of legal requirements regarding European medical devices.

Accordingly, when selecting the European agent, the agent must understand the legal requirements of medical devices rather than simply acting as a contact point and a company to be appointed is required to have experience in registering CE marked products in the applicable country.