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.
- 02 Dec 2027 Coupled to the Annex III high-risk applicability date
- Register the high-risk system in the EU database before placing it on the market or putting it into service.
- Where relying on the Article 6(3) carve-out, register the self-assessment that the system is not high-risk.
- Keep the registration entry up to date to reflect material changes to the system.
- Public-sector deployers should confirm the system they use has been registered by the provider before deployment.
- EU database registration record
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.
What regulators published on Art. 49
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- Regulation (EU) 2024/1689 on EUR-Lex
- Look for Article 49
- Deadline changes and the acts behind them
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Get free accessInformational content only. Not legal advice and not a substitute for qualified counsel. Dates reflect Regulation (EU) 2026/1744 as of 04 Aug 2026.