Medical Device Manufacturers require an:

European Authorized Representative in accordance with the 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:

FAQ click here.

To obtain an Authorized representative proposal for a Medical Device or IVDD Authorized Representative Click here.

Machinery EU Authorized Representative.

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 manufacturer's technical file or have quick assess to it. The Authorized Representative must have received 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.

The EU Commissions is strengthening its surveillance and enforcement of the CE mark program and requires that the first point of contact is the manufacturer's European Authorized Representative.

Release of a credible technical file should not be take 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 following application online. Click Here.