art_32__para_3

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

3. Importers shall indicate their name, registered trade name or registered trade mark, the postal address, website, email address or other digital contact details through which they can be contacted in a document accompanying the EHR system. The contact details shall indicate a single point at which the manufacturer can be contacted and shall be in a language which can be easily understood by users and market surveillance authorities. Importers shall ensure that any additional label does not conceal or obscure any of the information provided by the manufacturer that appears on any original label which is provided for the EHR system.

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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.