Documents to accompany the CE marking

The manufacturer has the responsibility to issue the Declaration of Performance and, when relevant by performance and uses of the product, it shall be accompanied by the security and/or use information.

In addition, the manufacturer shall have a technical dossier available stating the information used related to the process and the activities for the assessment, the issue of the Declaration of Performance and product CE marking.

The technical dossier shall include:

  • Product technical datasheet, plans, etc.
  • The harmonized standard or the European Technical Approval.
  • The documentation defined for the Assessment and Verification of Constancy of Performance (AVCP)
  • The factory production control manual.
  • The Appropriate Technical Documentation, if relevant.
  • The Specific Technical Documentation, if relevant.

The technical dossier has not to be given to the client; it has to be only available for the Administration or for the market surveillance authorities. It has to be kept a minimum of 10 years.

From ITeC, we can provide you with advice about the Declaration of Performance and Technical Dossier preparation.