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) 31: Non-EU manufacturers: appoint an EU authorised representative with a sufficient written mandate

Articles 30(4) and 31: a manufacturer established outside the Union appoints by written mandate an authorised representative in the Union before making a system available; the mandate lets it keep the declaration and documentation available for 10 years, provide documents and the mandate to authorities, inform the manufacturer of non-conformity and complaints, cooperate on corrective action and terminate the mandate on non-compliance; changes of representative are arranged in writing; the representative is jointly and severally liable if the manufacturer fails its obligations.

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

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