art_44__para_9

9. Where its tasks are not performed by the digital health authority, the market surveillance authority shall cooperate with the digital health authority. The market surveillance authority shall inform the digital health authority of any serious incidents, of EHR systems presenting a risk, including risks related to interoperability, security and patient safety, of any corrective action and of any recall or withdrawal of such EHR systems.

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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.