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Technical Record/Dossier


Each directive indicates the instances in which this documentation is necessary.

The technical record is an essential part of the conformity assessment procedure for a product, particularly when a Notified Body is not involved in the assessment procedure. It also facilitates the inspection work carried out by the Competent Authorities. When a Notified Body is involved, they will exert a certain level of control over the corresponding technical documentation, in accordance with the applicable module.

The information to be included will depend on the nature of the product. It will be necessary to include technical information to demonstrate the product’s conformity with either the harmonised standards or the essential requirements for the relevant directives when these standards have not been applied or have only been partially applied.

The document should contain the solutions adopted to ensure compliance with all the essential requirements applicable to the product.

It must be clear, concise, and not overcomplicated, and must be written in one of the European Union’s official languages. While each directive will request specific information, the following details are common to all:

a. Essential and useful technical data (to help assess conformity) such as:

  • Name and address of manufacturer, identification and description of product, list of harmonised standards applied.

  • Where relevant, instructions for use, blueprint and test certifications or audits carried out by Notified Bodies.

b. Complete documentation which includes.

  • Product and procedure descriptions.

  • Test reports.

  • Information about the quality system.

  • Plans.

  • List of standards applied, including harmonised standards..