CE Marking Technical File Requirements

Rules

The manufacturer must draw up technical documentation before the product or assembly of products is placed on the EU Market, whatever its geographical location
The technical documentation is intended to demonstrate that the design, manufacture and operation of the product are safe to use

Union harmonisation legislation obliges the manufacturer to draw up technical documentation containing information to demonstrate the conformity of the product or assembly to the applicable requirements.

As a rule, the documentation has to include a description of the product or assembly and of its intended use and cover the design, manufacture and operation of the product. The details included in the technical file depend on the nature of the product and on what is considered as necessary, from the technical point of view, for demonstrating the conformity of the product to the essential requirements of the relevant Union harmonisation legislation or, if the harmonised standards have been applied, to these by indicating the essential requirements covered by the standards.

The contents of the technical documentation that are relevant for proving the conformity of the product or assembly with the applicable harmonisation legislation. Furthermore, the requirement for an ‘adequate analysis and assessment of the risk(s)’ requires the manufacturer first to identify all possible risks of the product or assembly and determine the specific Union harmonisation legislation and essential requirements applicable.

This analysis has to be documented and included in the technical documentation. In addition, the manufacturer must document the assessment of how each identified risk is being addressed to ensure the product or assembly complies with the applicable essential requirements or harmonised standard.

What does the average typical technical file include

A list of Regulations or Directives that apply to the product or assembly you wish to CE Mark, remembering that there could be multiple Regulations or Directives that apply to the design of the product or assembly.
A list of Harmonised Standards or Non-Harmonised Standards used to demonstrate compliance
Risk Assessment against ISO 12100:2010
A risk assessment demonstrating how each clause has been addressed against the Essential Health and Safety Requirements of the applicable Directive applied or Harmonised Standards listed in the official Journal, and including the requirements of Annexe Zy of the applied standard if appropriate.
A list of tests conducted with their test results
Design Calculations (if applicable)
A Product description and specification, including all the variants and accessories used in the design. This is usually in the Instructions
A copy of the CE Marking nameplate in line with the applied standards used to demonstrate compliance.
Instructions for use detailing the transport and handling, installation and commissioning, operational requirements, maintenance, troubleshooting, parts list, decommissioning in all the languages accepted in the Member States where the product is foreseen to be sold;
A copy of an unsigned Declaration of Conformity or Declaration of Incorporation

In the case where a product has been subject to re-designs and re-assessments of the conformity, the technical documentation must reflect all versions of the product, describing the changes made, how the various versions of the product can be identified and information on the various conformity assessments. This is to avoid situations where, during the whole life of a product, a market surveillance authority is faced with previous versions of the product for which the version of the technical documentation presented is not applicable.

The technical documentation must be kept for 10 years from the date of placing the product on the market, unless the applicable Union harmonisation legislation expressly provides for any other duration. This is the responsibility of the manufacturer or the authorised representative established within the Union. Since the concept of ‘placing on the market’ refers to each individual product or assembly, the time period needs to be calculated from the moment when the individual product or assembly that is covered by the technical documentation is placed on the market.

Trust CE Marking Authority to guide you to success. Enhance your product's marketability and build a safer, more compliant future.

Contact us today! Visit cemarkingauthority.com or call +44 (0) 1779 841 842. Please email us at sales@cemarkingauthority.com.

About: About