EU AI Act Article 46: Derogation from the Conformity Assessment Procedure

No — Article 46 is not a way to skip conformity assessment. It is the EU AI Act's emergency-only valve: a national market surveillance authority can authorise placing a specific high-risk AI system on the market by derogation from the Article 43 procedure, but only on narrow public-interest grounds, only in its own Member State, and only for a limited period while the assessment is still being carried out. This guide covers Article 46 of Regulation (EU) 2024/1689 in full — the four exceptional grounds, the temporary nature, the notification machinery, the urgent law-enforcement carve-out, and where it sits in the timeline.

It applies to stand-alone Annex III high-risk systems. Annex I Section B product-embedded systems (motor vehicles, aviation, rail, marine) run through their own sectoral acts, so Article 46 is not the everyday path for them.

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What Article 46 actually is: a narrow derogation, not a shortcut

Article 46(1) lets a national market surveillance authority authorise the placing on the market or putting into service of a specific high-risk AI system within that Member State's territory, by derogation from the Article 43 conformity assessment procedure. That is the whole mechanism — an authority steps in, on public-interest grounds, to let a system go live before the normal pre-market gate has closed.

It is a tightly bounded exception. It is triggered only by exceptional reasons of public security or the protection of life and health of persons, environmental protection, and the protection of key industrial and infrastructural assets. Commercial convenience does not qualify. A missed launch date does not qualify. A backlog at a notified body does not qualify. The threshold is genuinely exceptional, public-interest circumstances — nothing less.

Keep it distinct from the routine routes. Under the normal Article 43 conformity assessment routes, a provider self-assesses under Annex VI or engages a notified body under Annex VII, and the assessment is the procedure. Article 46 does not replace that procedure; it buys time on it. The everyday path to market is Article 43. Article 46 is the exception you reach for when an emergency cannot wait.

Scope matters. This covers stand-alone Annex III high-risk systems, which take the Article 8–15 and Article 43 stack directly. Annex I Section B product-embedded systems are governed through their sectoral legislation, so Article 46 is not the everyday conformity path for them.

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The four exceptional grounds — and why they are exhaustive

Article 46(1) lists four grounds, and only four:

• public security;
• the protection of the life and health of persons;
• environmental protection; and
• the protection of key industrial and infrastructural assets.

The list is closed. An authority cannot invent a fifth ground, and a requesting party must map its situation onto one of these four. If your circumstances do not fit one of them, there is no derogation to be had — full stop.

Two further limits define the shape of any authorisation. First, it is limited to a specific high-risk AI system — not a product line, not a vendor's catalogue. Second, it is limited to the territory of the Member State whose authority grants it. An Article 46 authorisation does not confer EU-wide market access; it is single-territory permission, and a provider that wants to operate elsewhere must either complete Article 43 or seek a separate authorisation in each Member State concerned.

Note the change of actor. Under Article 43, the provider drives its own conformity route and makes its own declaration. Under Article 46, a public authority makes the decision, on public-interest grounds. The provider requests; the market surveillance authority decides.

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The temporary nature: authorisation runs only while assessment is carried out

This is the central thesis, and it is easy to get wrong: Article 46 buys time to run the assessment. It does not exempt the system from ever being assessed.

Article 46(1) ties the authorisation to a limited period while the conformity assessment under Article 43 is being carried out, and the authorisation is terminated as soon as that assessment is completed. The derogation waives the procedure's timing, not the substantive safety requirements behind it.

Article 46(3) makes that explicit. The authority grants an authorisation only where it concludes that the high-risk AI system complies with the Chapter III, Section 2 requirements — Articles 8 to 15: risk management, data governance, technical documentation, logging, transparency, human oversight, and accuracy, robustness and cybersecurity. The derogation removes the obligation to wait for the formal procedure; it does not remove the obligation to actually meet the requirements. A non-conforming system cannot be authorised under Article 46.

So the obligation to complete the Article 43 conformity assessment, and to CE-mark under Article 48, survives the derogation. Article 46 is a temporary, conditional permission. The conformity assessment must still happen — the clock simply runs in parallel rather than before market entry.

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The authorisation and notification procedure, step by step

An Article 46 authorisation is not a private decision between provider and authority. It is subject to EU-wide scrutiny.

Article 46(4) requires the authorising Member State to inform the Commission and the other Member States of the authorisation, without delay. Article 46(5)–(6) then opens a window: other Member States and the Commission may raise objections. Where no objection is raised within 15 calendar days of receiving the information, the authorisation is deemed justified. Where an objection is raised, the Commission enters consultations; if the authorisation is considered unjustified, it must be withdrawn by the market surveillance authority.

The practical lesson: a deemed-justified authorisation can still be challenged if the underlying facts were wrong, and a withdrawn authorisation leaves the system without a lawful basis.

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Article 46(2): the urgent law-enforcement and civil-protection carve-out

Article 46(2) is the narrowest sub-route. In a duly justified situation of urgency for exceptional reasons of public security, law enforcement authorities or civil protection authorities may put a specific high-risk AI system into service without the prior Article 46(1) authorisation.

This is act-first, authorise-after — but it does not cut the system loose from oversight. The authorisation must then be requested without undue delay during or after the use. If it is refused, use of the system must be stopped and all results and outputs immediately discarded. The carve-out applies to a defined set of public authorities, for genuine emergencies, and still funnels back into the authorisation and notification machinery in Article 46(4)–(6).

One hard limit. Article 46(2) does not override the Article 5 prohibitions. A use that is prohibited — for example the Article 5(1) practices such as untargeted scraping for facial-recognition databases or biometric categorisation inferring sensitive attributes — cannot be rescued by an urgency derogation. Article 46 presupposes a lawful high-risk system that simply has not yet completed its assessment. It cannot make a prohibited practice lawful.

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Comparison table: Article 46 derogation vs the Article 43 routes

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Worked example: a critical-infrastructure operator facing a flood emergency

Rhinewater is a 240-person regional water and flood-defence utility operating in a single EU Member State. It wants to deploy a high-risk AI flood-prediction and sluice-control system mid-crisis. The system is an Annex III point 2 critical-infrastructure use case. The provider has not yet completed the Article 43 conformity assessment, and an imminent flood threatens life, health, and key infrastructure.

The Article 46(1) path. Rhinewater's provider requests authorisation from the national market surveillance authority on protection-of-life-and-health and key-infrastructure grounds. The authority first confirms, under Article 46(3), that the system meets the Article 8–15 substantive requirements — risk management records, validated accuracy thresholds for sluice control, human-oversight controls so an operator can override an automated gate command. Satisfied, it grants an authorisation limited to that territory and time-boxed while the Article 43 assessment proceeds. It then informs the Commission and other Member States under Article 46(4); the 15-day objection window opens.

The Article 46(2) variant. Suppose there is no time to seek prior authorisation — the river is already cresting. A civil-protection authority could put the system into use immediately and request authorisation without undue delay. But if that request is later refused, it must stop using the system and discard all outputs the system produced.

Closing out. Either way, the temporary basis is not the destination. Rhinewater's provider must complete the Article 43 assessment, apply CE marking under Article 48, and register the system before the temporary authorisation lapses. Treating the derogation as the permanent operating basis would leave the system exposed the moment the assessment clock runs out.

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Deadlines, penalties, and where Article 46 sits in the timeline

High-risk obligations for stand-alone Annex III systems under Article 6(2) apply from 2 August 2026 in statute. A deferral to 2 December 2027 was adopted under the Digital Omnibus in June 2026 (European Parliament 16 June, Council 29 June). Plan against 2 December 2027.

Penalties bite if a derogation is mishandled. Breaching high-risk obligations is fineable up to €15 million or 3% of total worldwide annual turnover, whichever is higher (Article 99(4)). Supplying incorrect, incomplete, or misleading information to authorities — directly relevant to a flawed Article 46 request — is up to €7.5 million or 1% (Article 99(5)). Under Article 99(6), for SMEs and start-ups each fine is capped at the lower of the percentage or the fixed amount.

The practical takeaway: do not treat Article 46 as a planning tool. Relying on a derogation that is later objected to and withdrawn under Article 46(6) leaves the system non-compliant and exposed to enforcement. The derogation is for emergencies you could not foresee, not for deadlines you chose to ignore.

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How Confir helps

The precondition for any Article 46(3) authorisation is that the system already meets the Chapter III, Section 2 requirements. Confir's deterministic, rule-based engine maps a high-risk system against Articles 8 to 15 so that substantive-compliance precondition is evidenced, not assumed. It also tracks the live Article 43 conformity assessment that an Article 46 derogation runs alongside, so the temporary authorisation can be closed out the moment the assessment completes.

Confir is EU-positioned (confir.eu) and performs no model inference in-product — the engine is deterministic and rule-based, with no hallucination. It is documentation and obligation-tracking software, not a substitute for a market surveillance authority's decision.

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Related guides

• the normal Article 43 conformity assessment routes
• how EU AI Act conformity assessment works
• market surveillance authority
• the Article 47 EU declaration of conformity
• post-market monitoring obligations under Article 72