art_45__para_5

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

5. Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority concerned shall take all appropriate measures to prohibit or restrict the EHR system from being made available on the market or ensure that it is recalled or withdrawn from the market.

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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.