Technical Construction Files
UKCA or CE Marking Directives
Under UK and European Law, legislation obliges the manufacturer to draw up technical documentation containing information to demonstrate the conformity of the product to the applicable requirements. The technical documentation must be available when the product is placed on the market, whatever its geographical origin or location.
The technical documentation must be kept for 10 years from the date of placing the product on the market, unless the applicable 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, the time period needs to be calculated from the moment when the individual product that is covered by the technical documentation is placed on the market.
The contents of the technical documentation are laid down, in each statutory instrument or EU Directive, in accordance with the products concerned. As a rule, the documentation has to include a description of the product and of its intended use and cover the design, manufacture and operation of the product. The details included in the documentation 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 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 with the applicable legislation. Furthermore, the requirement for an “adequate analysis and assessment of the risk(s)” requires the manufacturer to first identify all possible risks of the product and determine the essential requirements applicable. This analysis has to be documented and included in the technical documentation. In addition, the manufacturer needs to document the assessment of how he is addressing the risks identified to ensure that the product complies with the applicable essential requirements (for example, by applying BS EN Standards). If only part of the standards is applied or it does not cover all applicable safety requirements listed in the legislation, then also the way applicable requirements not covered by the standards are dealt with should also be documented in the technical documentation.
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 assessment. 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 it is presented with is not applicable.
In order to carry out the conformity assessment procedures requiring third-party verification in a proper way, the documentation should always be in a language understood by the surveillance authority, (usually the language of the country where the technical file is stored) even if this has not been explicitly mentioned in the legislation.
Technical documentation will usually include:
• Risk assessments (ISO 12100)
• Technical description.
• Drawings, circuit diagrams, and photos.
• Bill of materials.
• Specification and, where applicable, Declarations of Conformity for the critical components and materials used.
• Details of any design calculations.
• Test reports and/or assessments.
• Original Manual
• Copy of the Declaration of Conformity.
Technical documentation can be made available in any format (i.e. paper or electronic) and must be held for a period of up to 10 years after the manufacture of the last unit.
Manufactures if selling from outside the UK to the UK must store the technical within the UK and detail the address on the declaration of conformity, this, also applies to Manufactures selling from outside the European Union to an EU member state must store their technical file in a EU Member state
HOW WE CAN HELP:
The CE Marking Authority can assist manufacturers, importers, into the UK or Europe by acting as their Authorised Representative.
• Provide the manufacturer with a written mandate appointing CE Marking Authority as an authorised representative and to store the EU Declaration of Conformity and a copy of the technical file for a minimum of ten years and to keep at the disposal of national market surveillance for the same period
• Reviewing technical file for compliance
• Storing the technical file in the UK
• Storing the technical file in Europe