Binds: Provider (conformity)
All obligations
EU AI Act Art.46: Derogation from conformity assessment procedure
Article 46 of the EU AI Act binds the provider (conformity). It requires Where a high-risk AI system is to be placed on the market or put into service before its conformity assessment. This page states what it requires, who it binds and the evidence to keep. Browsing is free; the conformance kit is USD 499.
Specifics
| Instrument | Regulation (EU) 2024/1689 (the EU AI Act), as amended by Regulation (EU) 2026/1744 |
|---|---|
| Article | Art.46 |
| Binds | Provider (conformity) |
| Group | Notified Bodies, Standards and Conformity Assessment |
| Evidence items | 5 |
| Linked NIST AI RMF controls | 0 |
| Linked ISO/IEC 42001 controls | 0 |
| Last updated |
Who does Art.46 bind?
The article binds the provider (conformity). The Act places each duty on a named party in the value chain, so a system can carry a provider duty and a deployer duty at once. Confirm your own position against the text; this page names the party, it does not rule on your facts.
Applies with the high-risk regime: 2 December 2027 for stand-alone systems listed in Annex III, and 2 August 2028 for AI embedded in regulated products listed in Annex I (Article 113, as amended by Regulation (EU) 2026/1744). See the full timeline.
What does Art.46 require?
Where a high-risk AI system is to be placed on the market or put into service before its conformity assessment is complete, for exceptional reasons of public security, protection of the life and health of persons, environmental protection or protection of key industrial and infrastructural assets, an authorisation must be obtained from the market surveillance authority on a duly justified request. The authorisation runs for a limited period while the conformity assessment procedures are carried out, and those procedures must be completed without undue delay. In a duly justified situation of urgency, law enforcement or civil protection authorities may put such a system into service before authorisation provided the authorisation is requested during or after the use without undue delay; if it is refused, use must stop with immediate effect and all results and outputs of that use must be discarded immediately. For high-risk AI systems related to products covered by Section A of Annex I, only the derogations in that legislation apply.
This is our plain-language statement of the article, not the text of the regulation. Read the article: Art.46 (Regulation (EU) 2024/1689 on EUR-Lex).
What evidence should we keep for Art.46?
| Category | Evidence to keep |
|---|---|
| Derogation | The duly justified request to the market surveillance authority, naming the exceptional ground relied on |
| Derogation | The authorisation received, with its scope and expiry recorded |
| Derogation | A plan and progress evidence showing the conformity assessment is being completed without undue delay while the authorisation runs |
| Derogation | For urgency use before authorisation, a record of when use began and when the authorisation was requested |
| Derogation | A stop and discard procedure able to demonstrably purge all results and outputs if the authorisation is refused |
What does a linked control mean here?
A linked control is a NIST AI RMF or ISO/IEC 42001 control that the held rule set records as a topical match, with a confidence and a one-line reason. It does not establish that meeting one requirement satisfies the other, it is not legal advice, and it is not certification. Where no control is recorded, the page says so and does not guess. Sources: the NIST AI RMF and ISO/IEC 42001.
Which NIST AI RMF controls line up with Art.46?
No NIST AI RMF control is recorded as a match for this obligation in the held rule set. It is left unlinked and marked, never guessed.
Which ISO/IEC 42001 controls line up with Art.46?
No ISO/IEC 42001 control is recorded as a match for this obligation in the held rule set. It is left unlinked and marked, never guessed.
What does the conformance kit add for Art.46?
The kit renders this obligation into your own role checklist with the evidence register, the linked controls and a CSV export, for USD 499 one off. See what is in the kit or open it.