art_43__para_7

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

7. For medical devices, in vitro diagnostic medical devices or high-risk AI systems referred to in Article 27(1) and (2), the responsible authorities for market surveillance shall be those referred to in Article 93 of Regulation (EU) 2017/745, Article 88 of Regulation (EU) 2017/746 or Article 70 of Regulation (EU) 2024/1689, as applicable.

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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.