art_30__para_3

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

3. Manufacturers of EHR systems shall keep the technical documentation referred to in Article 37 and the EU declaration of conformity referred to in Article 39 for 10 years after the EHR system covered by the EU declaration of conformity has been placed on the market. Manufacturers of EHR systems shall make available the source code or the programming logic included in the technical documentation, upon a reasoned request, to the relevant authorities, if that source code or programming logic is necessary in order for those authorities to be able to check compliance with the essential requirements laid down in Annex II.

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