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) 32: Importers: verify conformity before supply, keep records and act on non-conformity

Article 32: importers place only conforming systems on the market and first check the documentation and declaration exist, the manufacturer and representative are identified, the CE marking is affixed and the information sheet and instructions accompany it; they add their own contact details, do not alter the system in a way that affects conformity, withhold, recall or withdraw non-conforming systems and inform manufacturer, users and authorities, report risks to health or safety, keep the declaration for 10 years, cooperate with authorities, check or establish accessible complaint channels, keep registers and investigate complaints and incidents.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.