What documents are required for CE-marking?

The specific documents required for CE marking can vary depending on the type of product and the applicable EU directives or regulations. In general, the following documents represent key requirements that may be necessary to establish compliance for CE marking:

  • Technical Documentation: The New Approach directives and regulations require that the manufacturer compiles Technical Documentation including information that demonstrates compliance with the applicable European requirements. Together, these documents make up a product’s technical file.The contents of the technical file vary per directive/regulation, depending on the nature of the product and the information that is necessary to demonstrate that the product meets the essential requirements. In general, the design, manufacture and operation (user manual) of the product are described.
  • Declaration of Conformity (DoC): The most important document that is required for CE marking is the (EU/EC) Declaration of Conformity. The Declaration of Conformity declares that the responsible party (a manufacturer or their authorised representative) declares that their product meets the essential requirements of the applicable directives and/or regulations.

It’s important to note that the specific documents and requirements can vary significantly depending on the product’s category and the applicable EU directives and regulations. Manufacturers and importers should carefully review the relevant directives, regulations and standards. Should you contemplate seeking advice from legal or regulatory experts to guarantee complete compliance with CE marking requirements, please feel free to contact us without hesitation.

Knowledgebase

Related articles

Full-service product compliance

Leave it to us.