![]() ![]() 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. 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 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). This analysis has to be documented and included in the technical documentation. 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. ![]() The contents of the technical documentation that are relevant for proving the conformity of the product with the applicable legislation. 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. 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 contents of the technical documentation are laid down, in each statutory instrument or EU Directive, in accordance with the products concerned. 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. ![]() This is the responsibility of the manufacturer or the authorised representative established within the Union. 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. The technical documentation must be available when the product is placed on the market, whatever its geographical origin or location. 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. ![]()
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