Official text of Article 31
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.
Replaced from 26 March 2027 by Regulation (EU) 2025/327 DATE TO VERIFY
Article 104, point (2) of Regulation (EU) 2025/327 on the European Health Data Space (OJ L, 2025/327, 5.3.2025): “in Article 31, paragraph 3 is replaced by the following:”
- ‘3.
For products with digital elements as referred to in Article 12 and Article 32(5a), 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.’
Not yet applicable: the text above replaces or supplements this provision from 26 March 2027 (Article 105 of Regulation (EU) 2025/327, as read by regulation-cra.eu — to be verified). Amending act on EUR-Lex
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.