Art. 49

Article 49: Registration

Article 49 requires providers of Annex III high-risk systems to register the system in the EU database referred to in Article 71 before placing it on the market or putting it into service. Providers who conclude under Article 6(3) that their Annex III system is not high-risk must also register that self-assessment.

providerdeployer high-risk
When it applies
What it requires
What you keep on file
Commonly misread

Article 49 registration is often assumed to only apply to systems confirmed as high-risk; it also captures the Article 6(3) self-assessments where a provider decides a system is NOT high-risk, so the database is broader than a pure high-risk registry.

Unsettled: Whether the Digital Omnibus simplified the registration process itself (beyond documentation templates for small-mid-caps) was not verified in detail against the primary text.

Recent activity

What regulators published on Art. 49

  1. Loading from the public feed…

Informational content only. Not legal advice and not a substitute for qualified counsel. Dates reflect Regulation (EU) 2026/1744 as of 04 Aug 2026.