ObligationApplicablev1.0.0

Article 61: informed consent of test subjects for testing in real world conditions

If you test a high-risk AI system in real world conditions outside an AI regulatory sandbox, freely-given informed consent must be obtained from every test subject before they participate. Beforehand the subject receives concise, clear, relevant and understandable information on five prescribed topics: the nature and objectives of the testing and the possible inconvenience, the conditions under which the testing is to be conducted including the expected duration of participation, their rights and guarantees including the right to refuse and the right to withdraw at any time without detriment and without justification, the arrangements for requesting the reversal or the disregarding of the outputs of the system, and the Union-wide unique single identification number with the contact details from whom further information can be obtained. The consent is dated and documented and the subject is given a copy.

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-61-informed-consent
Payload hash (sha256): e7ff043231fa794c9c21494315ad879b5bac9ab1195f761cfec85493be5acd92

Citation line

Praxikon, "Article 61: informed consent of test subjects for testing in real world conditions", praxikon:eu:ai-act:obligation:article-61-informed-consent@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 e7ff043231fa794c9c21494315ad879b5bac9ab1195f761cfec85493be5acd92

Version: 1.0.0
Legal time (effective_at): 2 August 2026
Knowledge time (known_at): 6 September 2026
Closed on: Not closed
Application date: 2 August 2026
Topics: fundamental-rights, innovation

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.

Duty holder

Provider of an AI systempraxikon:eu:ai-act:actor:provider

Affected actor

Deployerpraxikon:eu:ai-act:actor:deployer

Oversight

Market surveillance authoritypraxikon:eu:ai-act:actor:market-surveillance-authority

Evidence owner

Provider of an AI systempraxikon:eu:ai-act:actor:provider

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 carries the duty

1 of 1 shown

The duty rests on this role. A supervisory authority addresses this role when it is not met.

Source
Official fact on this object, with its locator.
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 61(1) and (2)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allApplies for the purpose of testing in real world conditions under Article 60, that is where you are a provider or prospective provider of a high-risk AI system listed in Annex III and you test that system in real world conditions outside an AI regulatory sandbox. Article 60(4), point (i), makes informed consent in accordance with Article 61 one of the cumulative conditions under which such testing is allowed. Consent is obtained per subject prior to their participation. Article 61 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026.
- Condition | any ofIf under Article 60(2) you test in partnership with one or more deployers or prospective deployers, the condition stays with you as the provider, even where that party is the one in contact with the subject. Article 60(4), point (h), requires you and that party to conclude an agreement specifying your tasks and responsibilities; that is where you record who informs, who obtains the consent and who keeps the file.
- ExceptionThe only exception sits not in Article 61 but in Article 60(4), point (i): in the case of law enforcement, where seeking informed consent would prevent the AI system from being tested in real world conditions, testing may proceed without that consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test is performed. Outside that context there is no exception to consent; Article 61 contains none of its own.
As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.
Consequence
- ActorProvider of an AI system
  praxikon:eu:ai-act:actor:provider

Who is affected without being the addressee

1 of 1 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.

Source
Official fact on this object, with its locator.
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 61(1) and (2)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allApplies for the purpose of testing in real world conditions under Article 60, that is where you are a provider or prospective provider of a high-risk AI system listed in Annex III and you test that system in real world conditions outside an AI regulatory sandbox. Article 60(4), point (i), makes informed consent in accordance with Article 61 one of the cumulative conditions under which such testing is allowed. Consent is obtained per subject prior to their participation. Article 61 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026.
- Condition | any ofIf under Article 60(2) you test in partnership with one or more deployers or prospective deployers, the condition stays with you as the provider, even where that party is the one in contact with the subject. Article 60(4), point (h), requires you and that party to conclude an agreement specifying your tasks and responsibilities; that is where you record who informs, who obtains the consent and who keeps the file.
- ExceptionThe only exception sits not in Article 61 but in Article 60(4), point (i): in the case of law enforcement, where seeking informed consent would prevent the AI system from being tested in real world conditions, testing may proceed without that consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test is performed. Outside that context there is no exception to consent; Article 61 contains none of its own.
As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.
Consequence
- ActorDeployer
  praxikon:eu:ai-act:actor:deployer

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.

Source
Official fact on this object, with its locator.
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 61(1) and (2)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allApplies for the purpose of testing in real world conditions under Article 60, that is where you are a provider or prospective provider of a high-risk AI system listed in Annex III and you test that system in real world conditions outside an AI regulatory sandbox. Article 60(4), point (i), makes informed consent in accordance with Article 61 one of the cumulative conditions under which such testing is allowed. Consent is obtained per subject prior to their participation. Article 61 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026.
- Condition | any ofIf under Article 60(2) you test in partnership with one or more deployers or prospective deployers, the condition stays with you as the provider, even where that party is the one in contact with the subject. Article 60(4), point (h), requires you and that party to conclude an agreement specifying your tasks and responsibilities; that is where you record who informs, who obtains the consent and who keeps the file.
- ExceptionThe only exception sits not in Article 61 but in Article 60(4), point (i): in the case of law enforcement, where seeking informed consent would prevent the AI system from being tested in real world conditions, testing may proceed without that consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test is performed. Outside that context there is no exception to consent; Article 61 contains none of its own.
As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.
Consequence
- ActorMarket surveillance authority
  praxikon:eu:ai-act:actor:market-surveillance-authority

Who owns the evidence

1 of 1 shown

This duty holder creates, maintains and can produce the evidence.

Source
Official fact on this object, with its locator.
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 61(1) and (2)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allApplies for the purpose of testing in real world conditions under Article 60, that is where you are a provider or prospective provider of a high-risk AI system listed in Annex III and you test that system in real world conditions outside an AI regulatory sandbox. Article 60(4), point (i), makes informed consent in accordance with Article 61 one of the cumulative conditions under which such testing is allowed. Consent is obtained per subject prior to their participation. Article 61 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026.
- Condition | any ofIf under Article 60(2) you test in partnership with one or more deployers or prospective deployers, the condition stays with you as the provider, even where that party is the one in contact with the subject. Article 60(4), point (h), requires you and that party to conclude an agreement specifying your tasks and responsibilities; that is where you record who informs, who obtains the consent and who keeps the file.
- ExceptionThe only exception sits not in Article 61 but in Article 60(4), point (i): in the case of law enforcement, where seeking informed consent would prevent the AI system from being tested in real world conditions, testing may proceed without that consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test is performed. Outside that context there is no exception to consent; Article 61 contains none of its own.
As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.
Consequence
- ActorProvider of an AI system
  praxikon:eu:ai-act:actor:provider

What has to be done

1 of 1 shown

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

Source
Official fact on this object, with its locator.
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 61(1) and (2)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allApplies for the purpose of testing in real world conditions under Article 60, that is where you are a provider or prospective provider of a high-risk AI system listed in Annex III and you test that system in real world conditions outside an AI regulatory sandbox. Article 60(4), point (i), makes informed consent in accordance with Article 61 one of the cumulative conditions under which such testing is allowed. Consent is obtained per subject prior to their participation. Article 61 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026.
- Condition | any ofIf under Article 60(2) you test in partnership with one or more deployers or prospective deployers, the condition stays with you as the provider, even where that party is the one in contact with the subject. Article 60(4), point (h), requires you and that party to conclude an agreement specifying your tasks and responsibilities; that is where you record who informs, who obtains the consent and who keeps the file.
- ExceptionThe only exception sits not in Article 61 but in Article 60(4), point (i): in the case of law enforcement, where seeking informed consent would prevent the AI system from being tested in real world conditions, testing may proceed without that consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test is performed. Outside that context there is no exception to consent; Article 61 contains none of its own.
As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.
Consequence
- ActionInform the test subject and obtain consent to participate
  praxikon:eu:ai-act:action:article-61-inform-and-obtain-consent

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.

Source
Official fact on this object, with its locator.
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 61(1) and (2)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allApplies for the purpose of testing in real world conditions under Article 60, that is where you are a provider or prospective provider of a high-risk AI system listed in Annex III and you test that system in real world conditions outside an AI regulatory sandbox. Article 60(4), point (i), makes informed consent in accordance with Article 61 one of the cumulative conditions under which such testing is allowed. Consent is obtained per subject prior to their participation. Article 61 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026.
- Condition | any ofIf under Article 60(2) you test in partnership with one or more deployers or prospective deployers, the condition stays with you as the provider, even where that party is the one in contact with the subject. Article 60(4), point (h), requires you and that party to conclude an agreement specifying your tasks and responsibilities; that is where you record who informs, who obtains the consent and who keeps the file.
- ExceptionThe only exception sits not in Article 61 but in Article 60(4), point (i): in the case of law enforcement, where seeking informed consent would prevent the AI system from being tested in real world conditions, testing may proceed without that consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test is performed. Outside that context there is no exception to consent; Article 61 contains none of its own.
As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.
Consequence
- EvidenceInformation pack for subjects of testing in real world conditions
  praxikon:eu:ai-act:evidence:article-61-subject-information-pack

What keeps it in place

1 of 1 shown

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

Source
Official fact on this object, with its locator.
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 61(1) and (2)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allApplies for the purpose of testing in real world conditions under Article 60, that is where you are a provider or prospective provider of a high-risk AI system listed in Annex III and you test that system in real world conditions outside an AI regulatory sandbox. Article 60(4), point (i), makes informed consent in accordance with Article 61 one of the cumulative conditions under which such testing is allowed. Consent is obtained per subject prior to their participation. Article 61 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026.
- Condition | any ofIf under Article 60(2) you test in partnership with one or more deployers or prospective deployers, the condition stays with you as the provider, even where that party is the one in contact with the subject. Article 60(4), point (h), requires you and that party to conclude an agreement specifying your tasks and responsibilities; that is where you record who informs, who obtains the consent and who keeps the file.
- ExceptionThe only exception sits not in Article 61 but in Article 60(4), point (i): in the case of law enforcement, where seeking informed consent would prevent the AI system from being tested in real world conditions, testing may proceed without that consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test is performed. Outside that context there is no exception to consent; Article 61 contains none of its own.
As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.
Consequence
- ControlConsent and withdrawal review before a test in real world conditions starts
  praxikon:eu:ai-act:control:article-61-consent-and-withdrawal-review

Public tools

1 of 1 shown

This is the public route a reader can actually use.

Source
Official fact on this object, with its locator.
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 61(1) and (2)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allApplies for the purpose of testing in real world conditions under Article 60, that is where you are a provider or prospective provider of a high-risk AI system listed in Annex III and you test that system in real world conditions outside an AI regulatory sandbox. Article 60(4), point (i), makes informed consent in accordance with Article 61 one of the cumulative conditions under which such testing is allowed. Consent is obtained per subject prior to their participation. Article 61 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026.
- Condition | any ofIf under Article 60(2) you test in partnership with one or more deployers or prospective deployers, the condition stays with you as the provider, even where that party is the one in contact with the subject. Article 60(4), point (h), requires you and that party to conclude an agreement specifying your tasks and responsibilities; that is where you record who informs, who obtains the consent and who keeps the file.
- ExceptionThe only exception sits not in Article 61 but in Article 60(4), point (i): in the case of law enforcement, where seeking informed consent would prevent the AI system from being tested in real world conditions, testing may proceed without that consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test is performed. Outside that context there is no exception to consent; Article 61 contains none of its own.
As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.
Consequence
- TemplateFull text of Article 61
  praxikon:eu:ai-act:template:article-61-legal-text

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.

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 61(1) and (2)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allArises prior to the participation of every natural person who is a subject of testing in real world conditions under Article 60, and again where the nature, objectives, conditions or expected duration of the test change.
Relation recorded on: Inform the test subject and obtain consent to participate
Consequence
- ActionInform the test subject and obtain consent to participate
  praxikon:eu:ai-act:action:article-61-inform-and-obtain-consent
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 61(1) and (2)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
No condition or exception recorded on this object.
Relation recorded on: Consent and withdrawal review before a test in real world conditions starts
Consequence
- ControlConsent and withdrawal review before a test in real world conditions starts
  praxikon:eu:ai-act:control:article-61-consent-and-withdrawal-review
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 61(1) and (2)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
No condition or exception recorded on this object.
Relation recorded on: Information pack for subjects of testing in real world conditions
Consequence
- EvidenceInformation pack for subjects of testing in real world conditions
  praxikon:eu:ai-act:evidence:article-61-subject-information-pack
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 61(1) and (2)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph
  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 61
Consequence
- TemplateFull text of Article 61
  praxikon:eu:ai-act:template:article-61-legal-text

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: for the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to their participation in such testing and after their having been duly informed with concise, clear, relevant, and understandable information regarding: (a) the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation; (b) the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects participation; (c) their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having to provide any justification; (d) the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system; (e) the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be obtained. Paragraph 2 provides: the informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative.
- Locator: Article 61(1) and (2)praxikon:eu:ai-act:source:reg-eu-2024-1689Open official source
Article 60(4), point (i), sets as a condition: the subjects of the testing in real world conditions have given informed consent in accordance with Article 61, or in the case of law enforcement, where the seeking of informed consent would prevent the AI system from being tested, the testing itself and the outcome of the testing in the real world conditions shall not have any negative effect on the subjects, and their personal data shall be deleted after the test is performed. Article 60(5) provides: any subjects of the testing in real world conditions, or their legally designated representative, as appropriate, may, without any resulting detriment and without having to provide any justification, withdraw from the testing at any time by revoking their informed consent and may request the immediate and permanent deletion of their personal data. The withdrawal of the informed consent shall not affect the activities already carried out. Article 60(2), as replaced by Article 1, point (24), of Regulation (EU) 2026/1744, provides: providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III or covered by Union harmonisation legislation listed in Section A of Annex I in real world conditions at any time before the placing on the market or the putting into service of the high-risk AI system on their own or in partnership with one or more deployers or prospective deployers. Until 27 July 2026 that paragraph named only the Annex III route; the consent of Article 61 therefore now also applies when testing high-risk AI in a regulated product under Section A of Annex I.
- Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraphpraxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

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 place in this Regulation where the individual consent of a natural person is a condition. Nowhere else does the lawfulness of something you do turn on a signature from the person it affects. That makes it tempting to reuse the existing GDPR consent form, and that is exactly where it goes wrong. Consent under Article 61 is consent to take part in a test; it is one of the cumulative conditions in Article 60(4) under which you may test in real world conditions. Whether, and on what basis, personal data may be processed in that test is not governed by Article 61 and this Regulation does not say so here. That remains a question of data protection law, and you answer it separately. The two do not coincide and one does not replace the other. Look as well at the content of the five points, because two of them appear in no standard form. Point (e) requires the Union-wide unique single identification number of the testing from Article 60(4), point (c). That number arises on registration, so you can only approach the subject once that registration is done; anyone who recruits first and registers afterwards has inverted the order. Point (d) requires you to explain how someone can request the reversal or the disregarding of the predictions, recommendations or decisions of the system. That is not only information: Article 60(4), point (k), requires those outputs to be capable of being effectively reversed and disregarded. If you cannot describe that mechanism, it probably does not exist and your test design does not qualify.
- Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraphpraxikon:eu:ai-act:source:reg-eu-2024-1689Open official source
Note the difference between paragraph 1 and paragraph 2, because organisations usually build only one of the two. Paragraph 1 is about informing beforehand: concise, clear, relevant and understandable, on five topics. Paragraph 2 is about the evidence afterwards: the consent is dated, is documented, and the subject is given a copy. A tick box in an app that leaves a line in a log file does not satisfy paragraph 2: no copy was given and usually there is no dating that can be shown independently of the logging system. So build two artefacts rather than one: the information pack you hand over, and the dated consent record you keep and of which the subject holds a copy. A second point missed in the design is withdrawal. Article 61(1), point (c), promises the subject a right to withdraw at any time without detriment and without justification, and Article 60(5) works that out: withdrawal is always possible, immediate and permanent deletion of the personal data may be requested, and the withdrawal does not affect the activities already carried out. Anyone who promises that right in the form but has no route to carry it out has not delivered on the promise. The practical question is therefore not how your form reads, but who receives the withdrawal on Monday morning, within what period the data disappear, and where that is recorded. Finally, do not leave the division of roles implicit. If you test together with a deployer, that party is often the one facing the subject, while the condition stays with you as the provider. Article 60(4), point (h), gives you the instrument to settle that, and that is the agreement specifying your tasks and responsibilities.
- Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); 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.

Draw up an information pack per test that names each of the five points of paragraph 1 separately, and check the pack line by line against those five points rather than against your existing privacy notice. Obtain the Union-wide unique single identification number from the registration under Article 60(4), point (c), and put it in the pack together with the contact details of the provider or the legal representative before you approach the first subject. Under point (d), describe the concrete mechanism through which someone can request the reversal or the disregarding of an output, with the place the request arrives and the period within which it is handled. Record a dated consent per subject and give a copy to the subject or the legal representative; keep that record separately from your application logs, so you can show it without consulting the system. Set up a withdrawal route with a named recipient, a period and a processing step for the request for immediate and permanent deletion of personal data, and rehearse that route once before the test starts. In the agreement with your deployer under Article 60(4), point (h), record who informs, who obtains consent, who keeps the record and who receives a withdrawal. If you test in the law enforcement domain and are considering the exception in Article 60(4), point (i), record in advance why seeking consent would prevent the testing, and how you ensure that the test has no negative effect and that the personal data are deleted after the test.
- Locator: Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraphpraxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

When this applies

1Applies for the purpose of testing in real world conditions under Article 60, that is where you are a provider or prospective provider of a high-risk AI system listed in Annex III and you test that system in real world conditions outside an AI regulatory sandbox. Article 60(4), point (i), makes informed consent in accordance with Article 61 one of the cumulative conditions under which such testing is allowed. Consent is obtained per subject prior to their participation. Article 61 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026.
2If under Article 60(2) you test in partnership with one or more deployers or prospective deployers, the condition stays with you as the provider, even where that party is the one in contact with the subject. Article 60(4), point (h), requires you and that party to conclude an agreement specifying your tasks and responsibilities; that is where you record who informs, who obtains the consent and who keeps the file.

When this does not apply

The only exception sits not in Article 61 but in Article 60(4), point (i): in the case of law enforcement, where seeking informed consent would prevent the AI system from being tested in real world conditions, testing may proceed without that consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test is performed. Outside that context there is no exception to consent; Article 61 contains none of its own.

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 61: informed consent of test subjects for testing in real world conditions",
praxikon:eu:ai-act:obligation:article-61-informed-consent@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 e7ff043231fa794c9c21494315ad879b5bac9ab1195f761cfec85493be5acd92,
https://www.praxikon.com/en/verkenner/obligation/article-61-informed-consent
(https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-61-informed-consent&effective_at=2026-08-02&known_at=2026-09-06&lang=en, accessed 2026-09-20)

Short form

praxikon:eu:ai-act:obligation:article-61-informed-consent@1.0.0 (sha256 e7ff0432)

BibTeX

@misc{praxikon-eu-ai-act-obligation-article-61-informed-consent-1-0-0,
  author       = {{Praxikon}},
  title        = {Article 61: informed consent of test subjects for testing in real world conditions},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:obligation:article-61-informed-consent},
  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 e7ff043231fa794c9c21494315ad879b5bac9ab1195f761cfec85493be5acd92},
  url          = {https://www.praxikon.com/en/verkenner/obligation/article-61-informed-consent},
  urldate      = {2026-09-20},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:obligation:article-61-informed-consent@1.0.0",
    "type": "dataset",
    "title": "Article 61: informed consent of test subjects for testing in real world conditions",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:obligation:article-61-informed-consent",
    "URL": "https://www.praxikon.com/en/verkenner/obligation/article-61-informed-consent",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          9,
          6
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          9,
          20
        ]
      ]
    },
    "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 e7ff043231fa794c9c21494315ad879b5bac9ab1195f761cfec85493be5acd92; retrieved_from https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-61-informed-consent&effective_at=2026-08-02&known_at=2026-09-06&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

How to verify a reference later is set out in the methodology. Terms

For agents and integrations

This page and the machine output come from the same object and the same two time axes.

Open as JSON Open as JSON-LD Human explanation Read the methodology