When a medical device manufacturer is established outside of European Union, the manufacturer needs to appoint an authorised representative to place a medical device in one of the member states. An Authorized Representative is any person naturally or legally established in the European Community who can act on behalf of the manufacturer.
A written mandate/letter designating an authorised representative for a medical device manufacturer is mandatory. The authorised representative must provide a copy of the mandate to the competent authority when requested.
The authorised representative shall perform the following tasks specified in the agreement between it and the manufacturer.
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