art_31__para_4

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

4. Where the manufacturer is established outside the Union and has not complied with the obligations laid down in Article 30, the authorised representative shall be jointly and severally liable for non-compliance with this Regulation on the same basis as the manufacturer.

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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.