Source: OJ L 2024/2847, 20.11.2024Current language: EN
- Cyber resilience for products with digital elements
Basic legislative acts
- CRA regulation
Article 31 Technical documentation
The technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that the product with digital elements and the processes put in place by the manufacturer comply with the essential cybersecurity requirements set out in Annex I. It shall at least contain the elements set out in Annex VII.
The technical documentation shall be drawn up before the product with digital elements is placed on the market and shall be continuously updated, where appropriate, at least during the support period.
For products with digital elements as referred to in Article 12, which are also subject to other Union legal acts which provide for technical documentation, a single set of technical documentation shall be drawn up containing the information referred to in Annex VII and the information required by those Union legal acts.
The technical documentation and correspondence relating to any conformity assessment procedure shall be drawn up in an official language of the Member State in which the notified body is established or in a language acceptable to that body.
The Commission is empowered to adopt delegated acts in accordance with Article 61 to supplement this Regulation by adding elements to be included in the technical documentation set out in Annex VII to take account of technological developments, as well as developments encountered in the implementation process of this Regulation. To that end, the Commission shall strive to ensure that the administrative burden on microenterprises and small and medium-sized enterprises is proportionate.
Relevant recitals
Recital 93 Simplified technical documentation
In relation to microenterprises and small enterprises, in order to ensure proportionality, it is appropriate to alleviate administrative costs without affecting the level of cybersecurity protection of products with digital elements that fall within the scope of this Regulation or the level playing field among manufacturers. It is therefore appropriate for the Commission to establish a simplified technical documentation form targeted at the needs of microenterprises and small enterprises. The simplified technical documentation form adopted by the Commission should cover all the applicable elements related to technical documentation set out in this Regulation and specify how a microenterprise or a small enterprise can provide the requested elements in a concise way, such as the description of the design, development and production of the product with digital elements. In doing so, the form would contribute to alleviating the administrative compliance burden by providing the enterprises concerned with legal certainty about the extent and detail of information to be provided. Microenterprises and small enterprises should be able to choose to provide the applicable elements related to technical documentation in extensive form and not take advantage of the simplified technical form available to them.
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