CE Marking - Technical Construction File

General
Products which are to be provided with the CE marking shall be designed to comply with relevant requirements.

Products with the CE marking shall be produced in accordance with the design that was found to comply with relevant requirements.

This leaflet provides information about the "Technical Construction File" which is the basis of the conformity assessment of the design.

For each product with the CE marking the manufacturer shall issue a "Declaration of Conformity"; this document states that the product is in conformance with the approved design. A separate information leaflet on this declaration is available.

The File
Essentially the file shall provide the necessary evidence that the design is in accordance with relevant requirements.

The file shall identify the product and the requirements. It shall describe the assessment-activities, and contain the results of these activities.

Suggestions for file-elements are:

• Name of the company responsible for the design,
• Name and function of the employee responsible for the file,
• Name (of the product),
• Type-designation,
• Description:
  
  
  • photographs, brochures,
  • technical construction drawings,
  • material compositions,
  • schematic diagrams,
  • parts lists of components,
  • descriptions of components,
    

all different versions shall be described, as far as relevant,

• Copies of the users manual and service instructions, as far as applicable,
• List of applicable EU-directives,
• List of normative technical documents or standards used for the conformity assessment,
• Design calculations,
• Hazard analysis,
• Description of measures to reduce or eliminate hazards,
• Evaluation- and test-reports, indicating:
  
  
  • which evaluations and tests were performed,
  • methods of evaluations and tests,
  • evaluation- and test-equipment,
  • results of evaluations and tests,
  • acceptance criteria.
    
    
• Conclusion, indicating that the product complies with all relevant requirements.

If considered appropriate, descriptions and explanations to properly understand the documents, shall be provided.

It is the responsability of the manufacturer to decide about the assembly of the file.

Information sources
The manufacturer may use outside-sources for the file or sub-contract the file, in parts or completely.

Manufacturers may not have available all evaluation- and test-equipment as required by the technical standards. Specialized laboratories, like CEBEC, provide relevant evaluation- and testing services.

In all cases the manufacturer remains responsable for the contents of the file and should operate an adequate system to verify the contents of information received. This verification can be asked from third-party certification institutes or Notified Bodies, like CEBEC.

Administration of the file
The file-elements need to be available. It is not an absolute requirement that the file is available as a "physical" entity.

Manufacturers usually operate quality management systems or administration systems with document control procedures. The file-elements can be made available in accordance with these procedures.

Authorities and Notified Bodies will require insight in the administration system of the manufacturer. Upon their request, the file, as a "physical" entity, shall be made available on short notice (a few days).

Notified Body
Modules Aa, B and H, of the conformity assessment scheme, require the involvement of a Notified Body in the design-stage. It is the obligation of the Notified Body to verify the contents of the file and to repeat evaluations and tests if considered necessary.