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) 30(1)(i): Correct, withdraw or recall non-conforming systems and keep complaint and non-conformity registers

Article 30(1)(i) to (o) and (5): manufacturers take corrective action without undue delay, or recall or withdraw, where a system is or may be non-conforming, and tell the national authorities, distributors, representatives, importers and users (with timetable and date of conformity); inform them of mandatory preventive maintenance; provide information and cooperate with market surveillance authorities in the official language; establish complaint channels and keep registers of complaints and non-conforming systems, keeping distributors informed.

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

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