art_44__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. Where a market surveillance authority of one Member State has reason to believe that an EHR system poses a risk to the health, safety or rights of natural persons or to the protection of personal data, that market surveillance authority shall carry out an evaluation in relation to the EHR system concerned covering all relevant requirements laid down in this Regulation. The manufacturer, the manufacturer’s authorised representative and all other relevant economic operators shall cooperate as necessary with the market surveillance authority for that purpose and take all appropriate measures to ensure that the EHR system concerned no longer poses that risk when placed on the market or to recall or withdraw the EHR system from the market within a reasonable period.

← Article 44 · All articles · art_44__para_2 →

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