Regulation on the European Health Data Space (EHDS)
EHR systems: requirements and economic operators – Regulation on the European Health Data Space (EHDS)

Regulation on the European Health Data Space (EHDS) 39: Issue an Annex IV EU declaration of conformity and affix the CE marking before placing on the market

Articles 39 and 41 with Annex IV: the manufacturer draws up an EU declaration of conformity stating that Annex II is met (a single declaration where other Union acts also require one), containing the Annex IV information including the testing-environment result, translated as Member States require and, if digital, accessible online for the system's lifetime and at least 10 years; by doing so it takes responsibility for the harmonised components. The CE marking is affixed visibly, legibly and indelibly to accompanying documents and packaging before placing on the market, under Regulation 765/2008 principles.

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