art_27__para_1

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

1. Manufacturers of medical devices or in vitro diagnostic medical devices, as defined in Article 2, point (1), of Regulation (EU) 2017/745 and Article 2, point (2), of Regulation (EU) 2017/746, respectively, that claim interoperability of those medical devices or in vitro diagnostic medical devices with the harmonised software components of EHR systems shall prove compliance with the essential requirements on the European interoperability software component for EHR systems and the European logging software component for EHR systems, laid down in Section 2 of Annex II to this Regulation. Article 36 of this Regulation shall apply to those medical devices and in vitro diagnostic medical devices.

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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.