EHDS, Article 30, SE

1. Manufacturers of EHR systems shall:

(a)

ensure that the harmonised software components of their EHR systems and the EHR systems themselves, to the extent that this Chapter establishes requirements for them, are in conformity with the essential requirements laid down in Annex II and with the common specifications in accordance with Article 36;

(b)

ensure that the harmonised software components of their EHR systems are not adversely affected by other software components of the same EHR system;

(c)

draw up the technical documentation of their EHR systems in accordance with Article 37 before placing those EHR systems on the market, and subsequently keep it up to date;

(d)

ensure that their EHR systems are accompanied, free of charge for the user, by the information sheet provided for in Article 38 and clear and complete instructions for use;

(e)

draw up the EU declaration of conformity in accordance with Article 39;

(f)

affix the CE marking of conformity in accordance with Article 41;

(g)

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Source: NovaCopilot