Article 35

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

Economic operators shall, on request, identify the following to the market surveillance authorities, for 10 years from the date when the last EHR system covered by the EU declaration of conformity has been placed on the market: any economic operator that has supplied them with an EHR system; and any economic operator to which they have supplied an EHR system.

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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.