EU Authorised Representative

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.

How we assist you with this process?

Why Choose Us  

Contact us for free consultation: [email protected]