Regulation on the European Health Data Space (EHDS)
Wellness applications and registration – Regulation on the European Health Data Space (EHDS)

Regulation on the European Health Data Space (EHDS) 49: Register EHR systems and labelled wellness apps in the EU database before placing on the market

Article 49: before placing on the market or putting into service an EHR system or a labelled wellness application, the manufacturer or its authorised representative enters the required data (list to be set by delegated act) in the public EU database for registration of EHR systems and wellness applications, including for EHR systems the testing-environment results.

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

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