art_30__para_5

Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance) · European Union

5. Manufacturers of EHR systems shall, upon a reasoned request from a market surveillance authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the EHR system with the essential requirements laid down in Annex II and the common specifications referred to in Article 36, in a language which can be easily understood by that market surveillance authority. The manufacturers of EHR systems shall cooperate with the market surveillance authority, at its request, on any measures taken to eliminate the risks posed by an EHR system which they have placed on the market or put into service.

← art_30__para_4 · All articles · Article 31 →

Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.