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) 33: Distributors: check marking and documents before supply and report non-conformity

Articles 33 and 34: distributors verify the declaration, CE marking, information sheet and instructions and importer details before making a system available, do not alter it in ways that affect conformity, withhold non-conforming systems and inform the manufacturer or importer and authorities, report risks and cooperate; an importer, distributor or user that markets a system under its own name, modifies it so conformity may be affected, or changes its intended purpose becomes the manufacturer with all Article 30 duties.

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.