4.3 技術文書

Union harmonisation legislation obliges the manufacturer to draw up technical documentation containing information to demonstrate the conformity of the product to the applicable requirements. This documentation may be part of the quality system documentation where the legislation provides for a conformity assessment procedure based on a quality system (modules D, E, H and their variants). The technical documentation must be available when the product is placed on the market, whatever its geographical origin or location (218).

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 (219). 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 Union harmonisation act, 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 Union harmonisation legislation or, if the harmonised standards have been applied, to these by indicating the essential requirements covered by the standards. The requirements in Annex II of Decision No 768/2008/ EC refer to the contents of the technical documentation that are relevant for proving the conformity of the product with the applicable harmonisation 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 specific Union harmonisation legislation and 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 harmonised standards). If only part of the harmonised standard is applied or it does not cover all applicable essential requirements, then also the way applicable essential requirements not covered by it are dealt with should 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.

Some Union harmonisation acts require that the technical documentation is written in a language accepted by the notified body (220). 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 notified body, even if this has not been explicitly mentioned in the Union harmonisation legislation.