CE Medical has the expertise to act as official Authorised Representative for Medical Devise products in Europe when they comply to the European Medical Devise Directives.
For medical devices, it is compulsory to appoint an Authorised Representative, under the 3 Medical Devices Directives:
1. Medical Device Directive 93/42/EEC,
2. In Vitro Diagnostic Medical Device 98/79/EC, and
3. Active Implantable Medical Device 90/385/EE.
The non-EU manufacturer must appoint an Authorized Representative which must be established in the European Union member states and is appointed by the manufacturer to act on manufacturer’s behalf in carrying out any tasks relating to the certified product.
Appointing an Authorised Representative
CE Medical has specific services to act as an Authorized Representative. Once it’s been determined that the product(s) comply with European safety requirements, and if appointed by the manufacturer CE Medical can fulfil the role as an official European Authorised Representative.
As described in the CE marking Directives, the appointed Authorised 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 Authorised 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.
CE Medical responsibilities as European Authorised Representative
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.
Do not hesitate to contact one of our experts directly (+31 (0) 294 41 75 81) or make use of the contact form below for further information to appoint CE medical as Authorised Representative for your company .