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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

upon request, provide, in an official language of the Member State concerned, market surveillance authorities in that Member State with all the information and documentation necessary to demonstrate the conformity of the EHR systems which they have placed on the market or put into service 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.