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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

The essential requirements laid down in this Annex shall apply mutatis mutandis to medical devices, in vitro diagnostic medical devices, AI systems and wellness applications claiming interoperability with EHR systems.

← Essential requirements for the harmonised software components of EHR systems and for products for which interoperability with EHR systems has been claimed · All articles · 1. General requirements →

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