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

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.

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.

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.