The manufacturer is responsible for the certification procedures and, where applicable, conformity certification for a product. In basic terms, they must:

• Guarantee that the product complies with the essential requirements of the applicable directives.
• Sign the CE Declaration of Conformity.
• Complete the required documentation or technical file.
• Place the CE Marking on the product

The manufacturer has the option of appointing a legal agent or authorised representative. For some procedures which require mandatory certification, this figure is essential if the manufacturer is not resident within the European Union.

The legal agent or representative, appointed by the manufacturer and authorised to act within the European Union, may be responsible for certain obligations stipulated by the directives. These are generally administrative in nature, such as the creation of the technical documentation, presentation of the request for the CE type examination, or signing of the CE Declaration of Conformity.

When neither party is established in the European Union, as a general rule, the person who commercialises the product in the EU assumes all the responsibilities that would normally fall on the manufacturer or their representative.

This person must ensure that the product complies with the essential requirements and must be able to provide the necessary information (Declaration of Conformity, technical documentation, etc.) for control purposes.

A manufacturer who is based in the European Union may not use this system as a way of transferring their responsibility to third parties (resellers, wholesalers, users, etc.).