EU Authorized Representative
If your company is a medical device manufacturer that exports its products to Europe you are required to establish an Authorized Representative in the European Union. The EU Authorized Representative is the primary contact for the national Competent Authorities and the EU Commission. We have significant experience of working on behalf of clients all over the world as their EU Authorized Representative.
Why Do I Need an EU Authorized Representative?
The EU Medical Devices Directive states that non-EU medical device manufacturers need an EU Authorized Representative in Europe in order to be allowed to sell their products. Where a manufacturer does not have a registered place of business in the European Community, he shall designate a single European Authorized Representative (EC REP) as required by Article 14.2* of Council Directive 93/42/EEC amended by Directive 2007/47/EC drs.. is an authorized EC REP with office in Sweden. The definition of an authorized representative in Regulation 765/2008/EC establish that: An “authorized representative” acts on behalf of the manufacturer in relation to specified tasks with regard to the latter’s obligations under the relevant Community legislation.