Authorized Representative

LEGAL SUPPORT AND REPRESENTATION FOR THE EU

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.

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.
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Product Certification Approval CE Mark
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WHEREVER YOU ARE LOCATED

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 as seen to the right.

The delegation of tasks from the manufacturer to the Authorised/Authorized Representative must be explicit and should take place in writing, in particular to define the contents of the tasks and the limits of the representative’s powers.

Representative’s Tasks and Requirements

  • Your guideAct as contact person to respond to questions regarding the safety of a product
  • Legal assistanceDraw up and sign a declaration of conformity
  • RepresentationCooperate with regulators upon request
  • ComplianceEliminate any identified risks of examined products

The benefits

Legal AR Support

Let us do the job

Easy and Rapid feedback

Consult our legal experts

Assure compliance

Avoid liability risks and legal issues

Knowledge sharing

Gain experience and insight

Price and timeframe

Price ranges could vary based on the circumstances beforehand and therefore are given on request. The lead time is approximately two till four weeks depending on the given conditions. The timeframe and price are closely intertwined with the following factors:

  • The applicable legal framework
  • the needed representation
 

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