art_38__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. As an alternative to supplying the information sheet referred to in paragraph 1 of this Article with the EHR system, manufacturers may enter the information referred to in paragraph 2 of this Article into the EU database for registration of EHR systems and wellness applications referred to in Article 49.

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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.