art_44__para_8

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

8. The market surveillance authorities referred to in paragraph 7 shall inform the other market surveillance authorities, without delay, of the serious incident and the corrective action taken or envisaged by the manufacturer or required of it to minimise the risk of recurrence of the serious incident.

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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.