Medical device manufacturers require a European Authorized Representative in accordance with Medical Device Directive 93/42/EEC and IVD Directive 98/79/EC; "Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a Member State, he shall designate an authorized representative".
Frequently asked questions about the role of the European Authorized Representative can be read HERE.
To obtain an Authorized Representative proposal for a Medical Device or IVDD please complete the application online by clicking HERE.
Effective December 29, 2009 all non-European based machinery manufacturers are required to identify a 'person' or 'entity' established in the European Union who is authorized to keep the manufacturers technical file or have quick access to it. The Authorized Representative must have a written mandate (agreement) from the manufacturer before its name appears on the Declaration of Conformity along with the name and address of the manufacturer.
The term 'Authorized Representative' does not describe a sales and marketing function, it describes a CE compliance/regulatory affairs function only.
Release of a credible technical file should not be taken lightly since it contains confidential and proprietary/design information. It is therefore of great importance to appoint an established and knowledgeable EU Authorized Representative firm in accordance with an EU legal agreement that includes confidentiality.
To obtain an Authorized Representative for Machinery proposal please complete the application online by clicking HERE.