art_31__para_1

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

1. Prior to making an EHR system available on the Union market, a manufacturer of an EHR system established outside of the Union shall, by written mandate, appoint an authorised representative which is established in the Union.

← Article 31 · All articles · art_31__para_2 →

Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.