{"meta":{"dataset_id":"praxikon:sys:registry:dataset:ai-act-implementation-graph","dataset_version":"2.2.0","schema_version":"1.5.0","lang":"en","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","count":1,"filters":{"id":"praxikon:eu:ai-act:obligation:article-61-informed-consent","type":"obligation","role":null,"duty_holder":null,"topic":null},"identifiers":{"canonical_namespace":"praxikon","canonical_form":"praxikon:<jurisdiction>:<regulation>:<type>:<slug>","legacy_namespace":"raip","legacy_resolution":"permanent","resolved":{"id":"praxikon:eu:ai-act:obligation:article-61-informed-consent","role":null,"duty_holder":null}}},"data":[{"id":"praxikon:eu:ai-act:obligation:article-61-informed-consent","legacy_id":"raip:obligation:article-61-informed-consent","type":"obligation","slug":"article-61-informed-consent","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"e7ff043231fa794c9c21494315ad879b5bac9ab1195f761cfec85493be5acd92","label":"Article 61: informed consent of test subjects for testing in real world conditions","summary":"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.","topics":["fundamental-rights","innovation"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer"],"oversight_actor_ids":["praxikon:eu:ai-act:actor:market-surveillance-authority"],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-61-inform-and-obtain-consent"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-61-subject-information-pack"],"control_ids":["praxikon:eu:ai-act:control:article-61-consent-and-withdrawal-review"],"template_ids":["praxikon:eu:ai-act:template:article-61-legal-text"],"conditions":[{"id":"article-61-scope","operator":"all","description":"Applies 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."},{"id":"article-61-joint-testing","operator":"any","description":"If 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."}],"exceptions":[{"id":"article-61-law-enforcement-carve-out","operator":"not","description":"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."}],"statements":[{"kind":"official_fact","text":"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.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 61(1) and (2)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"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.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"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.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"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.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"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.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-61-informed-consent","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 61 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/61","label":"Read Article 61 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}}],"included":{"sources":[{"id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","title":{"nl":"EU AI-verordening 2024/1689","en":"EU Artificial Intelligence Act 2024/1689"},"publisher":{"nl":"Europees Parlement en Raad","en":"European Parliament and Council"},"canonical_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj","source_version":"original-oj-2024-07-12","verified_at":"2026-08-08T00:00:00.000Z","fingerprint_basis":"canonical_url|source_version|verified_at","source_record_hash_sha256":"bf0fca3e1fb47ce58924f6e736d572bb5db3812c3276c0b2891fbf328c42a5c6","review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"legacy_id":"raip:source:reg-eu-2024-1689"}]},"links":{"self":"https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-61-informed-consent&lang=en","alternate":"https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-61-informed-consent&lang=en&format=jsonld","licence":"https://www.praxikon.com/nl/legal/terms"}}