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Your official representative in Europe

Authorized Representative

In a number of cases, a manufacturer can and must appoint an authorized representative for the European Union to carry out certain tasks on their behalf. In that way, you can outsource certain tasks to a party with the right knowledge to carry out these tasks more efficiently.

Certification Experts has the authority to function as a European Representative in these tasks. Once we have determined that your product complies with the European safety requirements, we can take on the role of official representative.

Manufacturers of medical devices and machines from outside the EU are required to appoint a representative in Europe. Other manufacturers are free to choose a European Representative.

The representative does not act as a commercial representative, but is merely the contact person for the safety of a product. This is effective in case of questions from users or government agencies about the safety of your product.

Representative’s Tasks and Requirements

A manufacturer can be based anywhere, but the representative must be based within the European Union. Additionally, the delegation of tasks must be set out in a written agreement between the manufacturer and the representative.

Depending on the conformity assessment procedure and the relevant legislation of the European Union, the representative can carry out the following tasks:

  • Act as contact person to respond to questions regarding the safety of a product;
  • Apply a CE-marking;
  • Draw up and sign a declaration of conformity;
  • Make the declaration and technical documentation available for national regulators;
  • Cooperate with regulators upon request;
  • Provide required information and documentation regarding product safety to regulators;
  • Eliminate any identified risks of examined products.

Certification Experts can act as your official European Representative. Contact our experts if you have questions or for a quotation.

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