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ObligationApplicablev1.0.0

Article 46: derogation from conformity assessment procedure

By way of derogation from Article 43, a market surveillance authority may, upon a duly justified request, authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the Member State concerned, for exceptional reasons of public security, the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. The authorisation is for a limited period while the conformity assessment is carried out, and those procedures are completed without undue delay. Law-enforcement authorities and civil protection authorities may start without an authorisation in a situation of urgency, provided that it is requested without undue delay; if it is refused, use stops with immediate effect and all results and outputs are discarded. The authorisation is issued only if the system complies with the requirements of Section 2, goes to the Commission and the other Member States, and is deemed justified after fifteen calendar days without objection.

The official source remains authoritative. This is general information about obligations and not legal advice. See this object on the map

Address and citation

This object has an address of its own that is never renamed or reused. Store the identifier in your own file, not the title or the link.

Identifier
praxikon:eu:ai-act:obligation:article-46-derogation-from-conformity-assessment
Payload hash (sha256)
1750dded1098676522ac2284e471cb504967e1c6055f5c0a19d556778c2e3792

Citation line

Praxikon, "Article 46: derogation from conformity assessment procedure", praxikon:eu:ai-act:obligation:article-46-derogation-from-conformity-assessment@1.0.0, dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0 (schema 1.5.0), effective_at 2026-08-08T00:00:00.000Z, known_at 2026-09-06T00:00:00.000Z, sha256 1750dded1098676522ac2284e471cb504967e1c6055f5c0a19d556778c2e3792
Version
1.0.0
Legal time (effective_at)
2 August 2026
Knowledge time (known_at)
6 September 2026
Closed on
Not closed
Topics
conformity, enforcement

Review status: Placed against the official source (6 September 2026). Next check due by 5 March 2027. The check date is the knowledge date of this version; no later recheck has been recorded.

Who must act and who is affected

On an obligation the addressee is recorded separately from the party that is merely affected. That difference decides who a supervisory authority addresses and who has work to do without the duty resting on them.

No duty holder assigned

The addressee falls outside the roles this dataset models. The duty exists, it just does not rest on a role recorded here.

Duty holder

Not recorded on this object.

Affected actor

Oversight

Evidence owner

Not recorded on this object.

What this object links to

Every relation appears below as a path: from the source with its locator, through the conditions and exceptions of the object carrying the relation, to the consequence. A locator belongs to a statement in the data and not to a relation, so the source is the source anchor of the carrying object.

Who is affected without being the addressee

3 of 3 shown

This role is practically affected without being the addressee: it receives the information, has to cooperate, or absorbs the consequences in its own process.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(1)-(2)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(3)-(4)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(5)-(7)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | any ofThe authorisation may be granted only for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That list is the entire basis: a commercial interest, a delivery deadline or a tender date is not in it.
    • Condition | allA duly justified request is required, the authorisation comes from a market surveillance authority, it concerns specific high-risk AI systems, and it operates solely within the territory of the Member State concerned. It is moreover for a limited period while the necessary conformity assessment procedures are being carried out, and the completion of those procedures shall be undertaken without undue delay.
    • Condition | allThe authorisation is issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The derogation therefore concerns the procedure of Article 43 and not the substantive requirements of Articles 8 to 15: those must be met before the authorisation exists.
    • ExceptionParagraph 2 removes the prior authorisation in a duly justified situation of urgency for exceptional reasons of public security or in the case of a specific, substantial and imminent threat to the life or physical safety of natural persons. Only law-enforcement authorities and civil protection authorities may rely on it, and only for putting into service, provided that such authorisation is requested during or after the use without undue delay.
    • ExceptionParagraph 7 excludes this Article for high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I. There, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply. For a regulated product, Article 46 is therefore not a route.
    • ExceptionThe notification duty in paragraph 3 towards the Commission and the other Member States shall not cover sensitive operational data in relation to the activities of law-enforcement authorities. The authorisation itself stands; the flow of data around it is limited.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

Who supervises this

1 of 1 shown

This role supervises and receives the notifications. It is the institutional role, not the national body that fills it.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(1)-(2)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(3)-(4)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(5)-(7)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | any ofThe authorisation may be granted only for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That list is the entire basis: a commercial interest, a delivery deadline or a tender date is not in it.
    • Condition | allA duly justified request is required, the authorisation comes from a market surveillance authority, it concerns specific high-risk AI systems, and it operates solely within the territory of the Member State concerned. It is moreover for a limited period while the necessary conformity assessment procedures are being carried out, and the completion of those procedures shall be undertaken without undue delay.
    • Condition | allThe authorisation is issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The derogation therefore concerns the procedure of Article 43 and not the substantive requirements of Articles 8 to 15: those must be met before the authorisation exists.
    • ExceptionParagraph 2 removes the prior authorisation in a duly justified situation of urgency for exceptional reasons of public security or in the case of a specific, substantial and imminent threat to the life or physical safety of natural persons. Only law-enforcement authorities and civil protection authorities may rely on it, and only for putting into service, provided that such authorisation is requested during or after the use without undue delay.
    • ExceptionParagraph 7 excludes this Article for high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I. There, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply. For a regulated product, Article 46 is therefore not a route.
    • ExceptionThe notification duty in paragraph 3 towards the Commission and the other Member States shall not cover sensitive operational data in relation to the activities of law-enforcement authorities. The authorisation itself stands; the flow of data around it is limited.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What has to be done

1 of 1 shown

This is what concretely has to be done under the obligation.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(1)-(2)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(3)-(4)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(5)-(7)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | any ofThe authorisation may be granted only for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That list is the entire basis: a commercial interest, a delivery deadline or a tender date is not in it.
    • Condition | allA duly justified request is required, the authorisation comes from a market surveillance authority, it concerns specific high-risk AI systems, and it operates solely within the territory of the Member State concerned. It is moreover for a limited period while the necessary conformity assessment procedures are being carried out, and the completion of those procedures shall be undertaken without undue delay.
    • Condition | allThe authorisation is issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The derogation therefore concerns the procedure of Article 43 and not the substantive requirements of Articles 8 to 15: those must be met before the authorisation exists.
    • ExceptionParagraph 2 removes the prior authorisation in a duly justified situation of urgency for exceptional reasons of public security or in the case of a specific, substantial and imminent threat to the life or physical safety of natural persons. Only law-enforcement authorities and civil protection authorities may rely on it, and only for putting into service, provided that such authorisation is requested during or after the use without undue delay.
    • ExceptionParagraph 7 excludes this Article for high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I. There, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply. For a regulated product, Article 46 is therefore not a route.
    • ExceptionThe notification duty in paragraph 3 towards the Commission and the other Member States shall not cover sensitive operational data in relation to the activities of law-enforcement authorities. The authorisation itself stands; the flow of data around it is limited.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What has to be recorded

1 of 1 shown

This is what has to be in the file to show that the action was carried out.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(1)-(2)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(3)-(4)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(5)-(7)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | any ofThe authorisation may be granted only for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That list is the entire basis: a commercial interest, a delivery deadline or a tender date is not in it.
    • Condition | allA duly justified request is required, the authorisation comes from a market surveillance authority, it concerns specific high-risk AI systems, and it operates solely within the territory of the Member State concerned. It is moreover for a limited period while the necessary conformity assessment procedures are being carried out, and the completion of those procedures shall be undertaken without undue delay.
    • Condition | allThe authorisation is issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The derogation therefore concerns the procedure of Article 43 and not the substantive requirements of Articles 8 to 15: those must be met before the authorisation exists.
    • ExceptionParagraph 2 removes the prior authorisation in a duly justified situation of urgency for exceptional reasons of public security or in the case of a specific, substantial and imminent threat to the life or physical safety of natural persons. Only law-enforcement authorities and civil protection authorities may rely on it, and only for putting into service, provided that such authorisation is requested during or after the use without undue delay.
    • ExceptionParagraph 7 excludes this Article for high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I. There, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply. For a regulated product, Article 46 is therefore not a route.
    • ExceptionThe notification duty in paragraph 3 towards the Commission and the other Member States shall not cover sensitive operational data in relation to the activities of law-enforcement authorities. The authorisation itself stands; the flow of data around it is limited.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What keeps it in place

1 of 1 shown

This is what keeps compliance in place over time, periodic or event-driven.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(1)-(2)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(3)-(4)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(5)-(7)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | any ofThe authorisation may be granted only for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That list is the entire basis: a commercial interest, a delivery deadline or a tender date is not in it.
    • Condition | allA duly justified request is required, the authorisation comes from a market surveillance authority, it concerns specific high-risk AI systems, and it operates solely within the territory of the Member State concerned. It is moreover for a limited period while the necessary conformity assessment procedures are being carried out, and the completion of those procedures shall be undertaken without undue delay.
    • Condition | allThe authorisation is issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The derogation therefore concerns the procedure of Article 43 and not the substantive requirements of Articles 8 to 15: those must be met before the authorisation exists.
    • ExceptionParagraph 2 removes the prior authorisation in a duly justified situation of urgency for exceptional reasons of public security or in the case of a specific, substantial and imminent threat to the life or physical safety of natural persons. Only law-enforcement authorities and civil protection authorities may rely on it, and only for putting into service, provided that such authorisation is requested during or after the use without undue delay.
    • ExceptionParagraph 7 excludes this Article for high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I. There, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply. For a regulated product, Article 46 is therefore not a route.
    • ExceptionThe notification duty in paragraph 3 towards the Commission and the other Member States shall not cover sensitive operational data in relation to the activities of law-enforcement authorities. The authorisation itself stands; the flow of data around it is limited.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

Public tools

1 of 1 shown

This is the public route a reader can actually use.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(1)-(2)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(3)-(4)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(5)-(7)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | any ofThe authorisation may be granted only for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That list is the entire basis: a commercial interest, a delivery deadline or a tender date is not in it.
    • Condition | allA duly justified request is required, the authorisation comes from a market surveillance authority, it concerns specific high-risk AI systems, and it operates solely within the territory of the Member State concerned. It is moreover for a limited period while the necessary conformity assessment procedures are being carried out, and the completion of those procedures shall be undertaken without undue delay.
    • Condition | allThe authorisation is issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The derogation therefore concerns the procedure of Article 43 and not the substantive requirements of Articles 8 to 15: those must be met before the authorisation exists.
    • ExceptionParagraph 2 removes the prior authorisation in a duly justified situation of urgency for exceptional reasons of public security or in the case of a specific, substantial and imminent threat to the life or physical safety of natural persons. Only law-enforcement authorities and civil protection authorities may rely on it, and only for putting into service, provided that such authorisation is requested during or after the use without undue delay.
    • ExceptionParagraph 7 excludes this Article for high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I. There, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply. For a regulated product, Article 46 is therefore not a route.
    • ExceptionThe notification duty in paragraph 3 towards the Commission and the other Member States shall not cover sensitive operational data in relation to the activities of law-enforcement authorities. The authorisation itself stands; the flow of data around it is limited.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What points at this object

Objects hanging off this obligation

4 of 4 shown

The object belongs to this obligation. The source line it hangs off sits there.

  1. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(1)-(2)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(3)-(4)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(5)-(7)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allArises as soon as a high-risk system is needed for one of the four exceptional reasons sooner than the conformity assessment allows, and on every deployment by a law-enforcement or civil protection authority that may start without prior authorisation under paragraph 2. Does not arise for systems in products under Section A of Annex I: paragraph 7 excludes them.

    Relation recorded on: Prepare a derogation request and the exit plan that goes with it

    Consequence

  2. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(1)-(2)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(3)-(4)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(5)-(7)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Review of an authorisation expiring, being refused or withdrawn

    Consequence

  3. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(1)-(2)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(3)-(4)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(5)-(7)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: File accompanying a request to derogate from the conformity assessment

    Consequence

  4. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(1)-(2)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(3)-(4)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(5)-(7)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Full text of Article 46

    Consequence

What this object states

Official fact

Attributable to a named primary source, with a locator. Where they differ, the official source prevails.

  • Paragraph 1 provides the following. By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the Member State concerned, for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That authorisation shall be for a limited period while the necessary conformity assessment procedures are being carried out, taking into account the exceptional reasons justifying the derogation. The completion of those procedures shall be undertaken without undue delay. Paragraph 2 provides the following. In a duly justified situation of urgency for exceptional reasons of public security or in the case of specific, substantial and imminent threat to the life or physical safety of natural persons, law-enforcement authorities or civil protection authorities may put a specific high-risk AI system into service without the authorisation referred to in paragraph 1, provided that such authorisation is requested during or after the use without undue delay. If the authorisation referred to in paragraph 1 is refused, the use of the high-risk AI system shall be stopped with immediate effect and all the results and outputs of such use shall be immediately discarded.

  • Paragraph 3 provides the following. The authorisation referred to in paragraph 1 shall be issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The market surveillance authority shall inform the Commission and the other Member States of any authorisation issued pursuant to paragraphs 1 and 2. This obligation shall not cover sensitive operational data in relation to the activities of law-enforcement authorities. Paragraph 4 provides the following. Where, within 15 calendar days of receipt of the information referred to in paragraph 3, no objection has been raised by either a Member State or the Commission in respect of an authorisation issued by a market surveillance authority of a Member State in accordance with paragraph 1, that authorisation shall be deemed justified.

  • Paragraph 5 provides the following. Where, within 15 calendar days of receipt of the notification referred to in paragraph 3, objections are raised by a Member State against an authorisation issued by a market surveillance authority of another Member State, or where the Commission considers the authorisation to be contrary to Union law, or the conclusion of the Member States regarding the compliance of the system as referred to in paragraph 3 to be unfounded, the Commission shall, without delay, enter into consultations with the relevant Member State. The operators concerned shall be consulted and have the possibility to present their views. Having regard thereto, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and to the relevant operators. Paragraph 6 provides the following. Where the Commission considers the authorisation unjustified, it shall be withdrawn by the market surveillance authority of the Member State concerned. Paragraph 7 provides the following. For high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply.

Our interpretation

Our own reading. It can change without the law changing, and it is not the position of a supervisory authority.

  • This is the only route in the Regulation along which a high-risk AI system reaches the market or is put into service without a completed conformity assessment, and that is exactly why it is not a commercial route. Three things make that firm. The grounds are exhaustive and none of them is about the supplier: public security, the protection of life and health of persons, environmental protection, the protection of key industrial and infrastructural assets. A tight delivery deadline, a tender closing in, or a notified body with a waiting list are not among them. The derogation moreover concerns only the procedure of Article 43 and not the substance: paragraph 3 allows the authorisation only where the market surveillance authority concludes that the system complies with the requirements of Section 2. So it does not buy you time to do Articles 9 to 15 later; at most it buys time for the paperwork of the assessment. And it is closed off geographically: the authorisation operates within the territory of the Member State concerned, which means a system running on this basis in one Member State simply has no basis in the next. Note finally paragraph 7. For high-risk AI systems related to products under Section A of Annex I this Article is not a route: there, only the derogations of the sectoral harmonisation legislation apply. Anyone building a regulated product therefore looks for the exit in his own sectoral framework and not here.

    • Locator: Article 43(1), (2) and (4); Article 47(1); Article 48(1); Article 49(1); Article 79(1); Chapter III, Section 5, and Article 113, second paragraphpraxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

  • Paragraph 2 reverses the order and that is the heaviest part of this Article for whoever uses it. In a situation of urgency a law-enforcement authority or a civil protection authority may put the system into service first and request the authorisation afterwards, provided that happens without undue delay. The other side sits in the same sentence: if the authorisation is refused, use stops with immediate effect and all results and outputs of that use are immediately discarded. That is not a suspension but a rollback, and it reaches what was produced in the meantime. Anyone starting on this basis must therefore know in advance which decisions, files, alerts and derived datasets count as results and outputs and how they can be found; working out afterwards what the system touched is too late by then, and a decision that rested on such an output is left standing without support. There is also a European aftermath that lands on the requester without him being a party to it. The market surveillance authority informs the Commission and the other Member States, and after 15 calendar days without objection the authorisation is deemed justified. If an objection is raised, by a Member State or by the Commission, the Commission enters into consultations, the operators concerned are consulted and the Commission decides. If it considers the authorisation unjustified, the market surveillance authority withdraws it. For the organisation that means: an authorisation is not firm for the first fifteen days, and it stays withdrawable afterwards. Plan for those two moments, and make sure the conformity assessment genuinely continues in the meantime, because the text names no maximum duration and ties the limited period only to the completion of those procedures.

    • Locator: Article 43(1), (2) and (4); Article 47(1); Article 48(1); Article 49(1); Article 79(1); Chapter III, Section 5, and Article 113, second paragraphpraxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

Recommended step

A practical step we consider appropriate. Not an obligation following from the Regulation.

  • Treat this route as a contingency plan and not as a planning option. Establish, before you need it, whether it is open to you at all: if your system sits in a product from Section A of Annex I, paragraph 7 closes it and you look for the derogation in your sectoral framework. If it is open, draft the reasoning document now: which of the four exceptional reasons you invoke, on which facts, why delay is not possible, and why this system in particular. Add to it the evidence that the system complies with the requirements of Section 2, because without that conclusion the market surveillance authority cannot issue the authorisation. Record where the conformity assessment stands and what still has to happen, with an end date, and name the person who carries that procedure through while the system runs. If you prepare for the reversed order of paragraph 2, that comes with an exit plan written in advance: which decisions, files, alerts and derived datasets count as results and outputs, how they can be traced per system version, who discards them, within what period, and what happens to decisions that rested on them. Put the fifteen calendar days after the notification of paragraph 3 in your calendar as the moment the authorisation first counts as justified, and reckon with withdrawal after that. Finally, set out in supplier contracts who submits the request, who supplies the reasoning and who bears the cost if the authorisation is refused or withdrawn.

    • Locator: Article 43(1), (2) and (4); Article 47(1); Article 48(1); Article 49(1); Article 79(1); Chapter III, Section 5, and Article 113, second paragraphpraxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

When this applies

  1. 1The authorisation may be granted only for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That list is the entire basis: a commercial interest, a delivery deadline or a tender date is not in it.
  2. 2A duly justified request is required, the authorisation comes from a market surveillance authority, it concerns specific high-risk AI systems, and it operates solely within the territory of the Member State concerned. It is moreover for a limited period while the necessary conformity assessment procedures are being carried out, and the completion of those procedures shall be undertaken without undue delay.
  3. 3The authorisation is issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The derogation therefore concerns the procedure of Article 43 and not the substantive requirements of Articles 8 to 15: those must be met before the authorisation exists.

When this does not apply

  • Paragraph 2 removes the prior authorisation in a duly justified situation of urgency for exceptional reasons of public security or in the case of a specific, substantial and imminent threat to the life or physical safety of natural persons. Only law-enforcement authorities and civil protection authorities may rely on it, and only for putting into service, provided that such authorisation is requested during or after the use without undue delay.
  • Paragraph 7 excludes this Article for high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I. There, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply. For a regulated product, Article 46 is therefore not a route.
  • The notification duty in paragraph 3 towards the Commission and the other Member States shall not cover sensitive operational data in relation to the activities of law-enforcement authorities. The authorisation itself stands; the flow of data around it is limited.

Referring to this object

Citation block

Copy this reference into your advice, article or file. The identifier, the version and the hash keep the statement findable later, even once the dataset has moved on.

Reference

Praxikon, "Article 46: derogation from conformity assessment procedure",
praxikon:eu:ai-act:obligation:article-46-derogation-from-conformity-assessment@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0 (schema 1.5.0),
effective_at 2026-08-02T00:00:00.000Z, known_at 2026-09-06T00:00:00.000Z,
sha256 1750dded1098676522ac2284e471cb504967e1c6055f5c0a19d556778c2e3792,
https://www.praxikon.com/en/verkenner/obligation/article-46-derogation-from-conformity-assessment
(https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-46-derogation-from-conformity-assessment&effective_at=2026-08-02&known_at=2026-09-06&lang=en, accessed 2026-09-21)

Short form

praxikon:eu:ai-act:obligation:article-46-derogation-from-conformity-assessment@1.0.0 (sha256 1750dded)

BibTeX

@misc{praxikon-eu-ai-act-obligation-article-46-derogation-from-conformity-assessment-1-0-0,
  author       = {{Praxikon}},
  title        = {Article 46: derogation from conformity assessment procedure},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:obligation:article-46-derogation-from-conformity-assessment},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.2.0, schema 1.5.0},
  note         = {effective_at 2026-08-02T00:00:00.000Z; known_at 2026-09-06T00:00:00.000Z; sha256 1750dded1098676522ac2284e471cb504967e1c6055f5c0a19d556778c2e3792},
  url          = {https://www.praxikon.com/en/verkenner/obligation/article-46-derogation-from-conformity-assessment},
  urldate      = {2026-09-21},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:obligation:article-46-derogation-from-conformity-assessment@1.0.0",
    "type": "dataset",
    "title": "Article 46: derogation from conformity assessment procedure",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:obligation:article-46-derogation-from-conformity-assessment",
    "URL": "https://www.praxikon.com/en/verkenner/obligation/article-46-derogation-from-conformity-assessment",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          9,
          6
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          9,
          21
        ]
      ]
    },
    "note": "dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0; schema 1.5.0; effective_at 2026-08-02T00:00:00.000Z; known_at 2026-09-06T00:00:00.000Z; sha256 1750dded1098676522ac2284e471cb504967e1c6055f5c0a19d556778c2e3792; retrieved_from https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-46-derogation-from-conformity-assessment&effective_at=2026-08-02&known_at=2026-09-06&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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