§7.4.1.1 Requesting compliance documentation

Union harmonisation legislation provides for two different tools that enable market surveillance authorities to receive information on the product: the EU declaration of conformity and the technical documentation. These must be made available by the manufacturer, the authorised representative established within the Union or under certain circumstances by the importer or the fulfilment service provider established within the Union (293). Other natural or legal persons, such as distributors are in principle not obliged to make these available (294). However, they are expected to assist the market surveillance authority in obtaining them. Further, the market surveillance authority may request the notified body to provide information on the conduct of conformity assessment for the product in question. The EU declaration of conformity must be made available to the market surveillance authority without delay upon request (295). It shall accompany the product where so required by specific Union harmonisation legislation. The technical documentation must be made available to the market surveillance authority within a reasonable period of time, in response to a reasoned request (Article R2(9) of Annex I to Decision No 768/2008). The authority cannot request it systematically. In general, it can be requested during checks made for market surveillance purposes, or when there are grounds for concern that a product does not offer the level of protection required in all respects. More detailed information (for example certificates and decisions from the notified body) can, nevertheless, be requested in cases of doubt about the conformity of the product to the applicable Union harmonisation legislation (Article R2(9) of Annex I to Decision No 768/2008). The full technical documentation should be requested only where clearly necessary, and not, for example, when only a detail has to be checked. This request has to be evaluated in accordance with the principle of proportionality and, thus, taking into account the need to ensure the health and safety of persons or other public interests foreseen in the applicable Union harmonisation legislation, as well as to protect the economic operators from unnecessary burden. Furthermore, failure to present the documentation in response to a reasoned request by a national market surveillance authority, within an acceptable timeframe, is a non-compliance and may constitute sufficient grounds for doubting the conformity of the product with the essential requirements of the applicable Union harmonisation legislation. In the case of a reasoned request, it is sufficient for the manufacturer to provide the part of the technical documentation related to the claimed non-conformity and appropriate for demonstrating whether the issue has been dealt with by the manufacturer. Therefore, any request for translation of technical documentation should be limited to these parts of the documentation. If the market surveillance authority considers a translation necessary, it must clearly indicate the part of the documentation to be translated and allow reasonable time for this to take place. No further conditions may be imposed on the translation, such as a requirement of a translator accredited or recognised by the public authorities. A national authority might accept a language they understand and which is different from the national language(s). The language chosen could be a third language, if accepted by that authority. It must be possible to make the technical documentation available in the Union. However, it does not need to be kept inside the Union, unless otherwise provided for in the applicable Union harmonisation legislation. The requirement for making it available does not mean that the economic operator who carries this obligation has to store it itself (296), as long as he is capable of presenting it on request from the national authority. Further, the technical documentation can be kept and sent to market surveillance authorities in paper or electronic form, which allows it to be made available within a period of time commensurate with the risk or non-compliance in question. Member States must ensure that everyone receiving information about the contents of the technical documentation during market surveillance activities is bound to confidentiality according to principles laid down in the national legislation.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07