What is a authorized representative
As described in the CE marking Directives, the appointed Authorized Representative established in the European Union must be able to act on behalf of the manufacturer. The delegation of tasks from the manufacturer to the Authorized Representative must be explicit and should take place in writing, in particular to define and to refrain the contents of the tasks and the limits of the representative.
Depending on the conformity assessment procedure and the Directives in question, the European Authorized Representative can, for instance, be appointed to ensure and declare that the product complies with the requirements, to affix the CE marking, to draw up and sign the EC declaration of conformity, or to keep the declaration and have access to the technical documentation for national surveillance authorities.
How can we assist you
As described in the CE marking legislation, the appointed Authorised Representative must be established with in the European Union.
The tasks that may delegated to the Authorised Representative are of an administrative nature. Depending on the conformity assessment procedure and the applicable European Union legislative act in question, the Authorised Representative can be appointed to:
- Affix the CE marking;
- Draw up and sign the Declaration of Conformity;
- Keep the Declaration and have access to the Technical Documentation for the disposal of national surveillance authorities and cooperate with them at their request;
- Upon a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product;
- Cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.
CE Medical acts as official European Authorised Representative for many companies globally who are exporting there Medical Devise products to the European union.
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