Frequently Asked Questions about the role of the European Authorized Representative:

Why do we need to select an Authorized Representative if we are located outside Europe?
What are our options?
How do we choose between an agent, distributor and an independent Authorized Representative?
Do independent Authorized Representatives sell medical devices in Europe?
How do we select an Authorized Representative?
Which of the Authorized Representative's essential duties are listed in the Medical Device Directive 93/42/EEC and what should we ask for in addition?
Why should the Authorized Representative sign the manufacturer's Declaration of Conformity?
What does the Authorized Representative expect from us, the manufacturer?
Why do we need to place a partial technical file with our Authorized Representative in Europe?
How do we keep this technical file up to date?
Is all the information we place with the Authorized Representative confidential?
What are the Authorized Representative's obligations and liabilities if the manufacturer's devices are not in compliance?
Is product liability covered by the Authorized Representative agreement?
Why do Authorized Representative agreements include a penalty clause in case of contractual violation by the manufacturer?
If we cancel our Authorized Representative agreement do all duties stop immediately?

For the answers to these questions click here.

Click here to complete the request form for a Medical Device Authorized Representative.

Frequently Asked Questions about CE Marking:

Who Are All These CE People?

Machinery Authorized Representative Clarified for Manufacturers
Assigning of an European Union (EU) Authorized Representative by American and Canadian machinery manufacturers has been clarified.

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.

QNET B.V. Amstenrade The Netherlands with offices in Minnesota USA, is a professional EU Authorized Representative firm in accordance with the Machinery, Medical and In-Vitro Diagnostic Directives, whose knowledgeable CE compliance managers have performed Authorized Representative services since 1998.

To obtain an Authorized Representative proposal please complete the following application online. Click Here.

USA Medical- FDA United States Agent for Devices

U.S FDA Regulations Section 417 requires that any establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device imported into the United States must register with the FDA and identify: the name and address of the establishment; and the name of the United States agent for the establishment.
Click here for the application form.

For additional information about our consulting services please click here.

USA FDA 510(k) Preparation  -Details here.

EU Medical/IVD CE Marking Services -Details Here.