{"answer_id":"praxikon:eu:ai-act:answer:instructies-voor-gebruik","canonical_page":"https://www.praxikon.com/en/antwoord/instructies-voor-gebruik","query":"What instructions for use must we supply with our AI system?","lang":"en","view":"full","mode":"scenario","question":"What instructions for use must we supply with our AI system?","situation":"You supply a high-risk AI system to another organisation. They must be able to use it as you intended, which is only possible if you supply what the system can and cannot do.","likely_role":"Provider (you place the system on the market)","note":"The instructions for use are not a manual but a legal document: they define the intended purpose, and therefore when a deployer steps outside your boundaries and becomes a provider themselves. Include the known limitations, the expected level of accuracy and how human oversight is meant to work.","matched_terms":[],"dataset":{"id":"praxikon:sys:registry:dataset:ai-act-implementation-graph","version":"2.2.0","schema_version":"1.5.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","last_reviewed_at":"2026-08-08T00:00:00.000Z","licence":"https://www.praxikon.com/nl/legal/terms","canonical_url":"https://www.praxikon.com/api/v1/entities"},"obligations":[{"slug":"article-13-instructions","label":"Article 13: transparency towards deployers","summary":"Comprehensible instructions for use and system information so deployers can operate the system correctly.","legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","high_risk_regime_from":null,"human_page":"https://www.praxikon.com/en/verplichtingen/article-13-instructions","api":"https://www.praxikon.com/api/v1/obligations?lang=en","official_source":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","citations":[{"kind":"official_fact","statement":"Article 13 requires high-risk systems to be designed transparently enough for deployers to interpret and use the output, with instructions covering purpose, accuracy, limitations, human oversight and maintenance.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 13(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"official_fact","statement":"For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.","source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"kind":"editorial_interpretation","statement":"The instructions are the hinge between provider and deployer duties: what the provider fails to supply here, the deployer cannot deliver under Article 26. Ask for it explicitly at procurement.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 13(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"recommended_action","statement":"Translate received instructions per system into internal work instructions per role and record who received them.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 13(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}]},{"slug":"annex-iii-high-risk","label":"Annex III: high-risk AI","summary":"Classification route for standalone high-risk AI systems under Article 6(2) and Annex III.","legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","high_risk_regime_from":null,"human_page":"https://www.praxikon.com/en/verplichtingen/annex-iii-high-risk","api":"https://www.praxikon.com/api/v1/obligations?lang=en","official_source":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","citations":[{"kind":"official_fact","statement":"The core rules in Chapter III, Sections 1 to 3, for systems under Article 6(2) and Annex III become applicable on 2 December 2027.","source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113, Article 6(2) and Annex III application date","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"kind":"editorial_interpretation","statement":"The later application date does not remove the classification question. An early classification record avoids design and procurement decisions without evidence.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6 and Annex III","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"recommended_action","statement":"Document now the intended purpose, Annex III point, Article 6(3) assessment, profiling and selected registration path.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6(2)-(4), Article 49 and Annex III","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}]},{"slug":"conformity-ce-registration","label":"Articles 43-49: conformity assessment, CE and registration","summary":"The route from assessment to CE marking and EU database registration before market placement of high-risk AI.","legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","high_risk_regime_from":"2027-12-02T00:00:00.000Z","human_page":"https://www.praxikon.com/en/verplichtingen/conformity-ce-registration","api":"https://www.praxikon.com/api/v1/obligations?lang=en","official_source":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","citations":[{"kind":"official_fact","statement":"Article 43 governs the conformity assessment, Article 47 the EU declaration of conformity, Article 48 the CE marking and Article 49 the registration in the EU database before market placement or putting into service, including registration of the Article 6(3) assessment.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 43, 47, 48 and 49","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"official_fact","statement":"This provision is named in none of the three points of Article 113, third paragraph, and therefore falls under the general application date in the second paragraph: 2 August 2026. The move to 2 December 2027 and 2 August 2028 in point (c) concerns only Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5). When a high-risk AI system that this provision addresses can practically exist is a second question: through Article 6(2) and Annex III that is 2 December 2027, and through Article 6(1) and Annex I 2 August 2028. That practical date sits in high_risk_regime_from and not in deadline_at. This is how decision D1 of 6 September 2026 is recorded; see data/ai-act/review/decision-d1-application-dates.json.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"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"},{"kind":"official_fact","statement":"This provision is named in none of the three points of Article 113, third paragraph, and therefore falls under the general application date in the second paragraph: 2 August 2026. The move to 2 December 2027 and 2 August 2028 in point (c) concerns only Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5). When a high-risk AI system that this provision addresses can practically exist is a second question: through Article 6(2) and Annex III that is 2 December 2027, and through Article 6(1) and Annex I 2 August 2028. That practical date sits in high_risk_regime_from and not in deadline_at. This is how decision D1 of 6 September 2026 is recorded; see data/ai-act/review/decision-d1-application-dates.json.","source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"kind":"editorial_interpretation","statement":"For buyers this is the simplest supplier check there is: ask for the declaration of conformity and the registration number. No declaration means the system may not be there by 2 December 2027.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 43, 47, 48 and 49","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"recommended_action","statement":"Plan the conformity route backwards from 2 December 2027: standards selection, assessment, declaration and registration together take months, not weeks.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 43, 47, 48 and 49","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}]},{"slug":"article-18-document-retention","label":"Article 18: documentation keeping","summary":"The provider of a high-risk AI system keeps the technical documentation, the quality management system documentation, the changes approved by notified bodies and the decisions they issued, and the EU declaration of conformity at the disposal of the national competent authorities for a period ending ten years after the system has been placed on the market or put into service.","legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","high_risk_regime_from":null,"human_page":"https://www.praxikon.com/en/verplichtingen/article-18-document-retention","api":"https://www.praxikon.com/api/v1/obligations?lang=en","official_source":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","citations":[{"kind":"official_fact","statement":"Paragraph 1 provides that the provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, keep at the disposal of the national competent authorities: (a) the technical documentation referred to in Article 11; (b) the documentation concerning the quality management system referred to in Article 17; (c) the documentation concerning the changes approved by notified bodies, where applicable; (d) the decisions and other documents issued by the notified bodies, where applicable; (e) the EU declaration of conformity referred to in Article 47. Paragraph 2 provides that each Member State shall determine conditions under which that documentation remains at the disposal of the national competent authorities for the period indicated for the cases when a provider or its authorised representative established on its territory goes bankrupt or ceases its activity prior to the end of that period. Paragraph 3 provides that providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the technical documentation as part of the documentation kept under the relevant Union financial services law.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 18(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"official_fact","statement":"The amended application dates for Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5), are 2 December 2027 for the standalone Annex III route and 2 August 2028 for high-risk AI in products covered by the Annex I harmonisation legislation.","source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"kind":"editorial_interpretation","statement":"Four things here are our reading and not the text. First the application date: Regulation (EU) 2026/1744 does not name Article 18 separately, so the fact that this duty moves with 2 December 2027 and 2 August 2028 follows from its placement in Chapter III, Section 3, and not from an explicit provision. Second the starting moment. Paragraph 1 names the placing on the market and the putting into service side by side without choosing, and for a system where both moments occur that is years of difference at the end of the period. Counting from the later moment is the only count that falls short under neither reading, and that is what we would advise a provider. The other reading is defensible: in Union product law the placing on the market is usually the moment that counts, and then the period ends earlier. Third a substantially modified version: the text is silent, and it is equally defensible that every version gets its own period as that the original one continues. Fourth the reach of paragraph 3: it names only the technical documentation, so we keep points (b) to (e) under the general regime until the contrary is settled. Paragraph 2, finally, is addressed to the Member State and not to you. The Netherlands has not yet determined those conditions, so what happens to your file on insolvency or cessation of activity currently follows from contract and not from law.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 18(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"recommended_action","statement":"Designate per high-risk system one place of retention where the five components of paragraph 1 come together. Record side by side when the system was placed on the market and when it was put into service, and calculate the end date from the later of those two moments, so that you do not fall short under either reading. Set that end date as a commitment in a system that survives a change of staff, and keep the Article 19 logs separately with their own period. If you work with an authorised representative, record who holds which copy, because Article 22(3)(b) places the same availability on them as well. When procuring a high-risk system, put in the contract what happens to the documentation if the supplier stops or goes bankrupt, because paragraph 2 leaves that arrangement to national law that does not yet exist in the Netherlands.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 18(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}]},{"slug":"article-16-provider-obligations","label":"Article 16: the twelve duties of a provider of a high-risk AI system","summary":"Article 16 is the summary list of duties for providers: twelve points that route onward to the quality management system, the documentation, the logs, the conformity assessment, the EU declaration of conformity, the CE marking, the registration, corrective actions and accessibility requirements.","legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","high_risk_regime_from":null,"human_page":"https://www.praxikon.com/en/verplichtingen/article-16-provider-obligations","api":"https://www.praxikon.com/api/v1/obligations?lang=en","official_source":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","citations":[{"kind":"official_fact","statement":"Article 16 requires providers of high-risk AI systems to do twelve things. They must ensure their systems comply with the requirements of Chapter III, Section 2 (point (a)); indicate on the system or, where that is not possible, on its packaging or accompanying documentation, their name, registered trade name or registered trade mark and the address at which they can be contacted (point (b)); have a quality management system in place complying with Article 17 (point (c)); keep the documentation referred to in Article 18 (point (d)); keep the automatically generated logs referred to in Article 19 when under their control (point (e)); ensure the system undergoes the conformity assessment procedure referred to in Article 43 prior to being placed on the market or put into service (point (f)); draw up an EU declaration of conformity in accordance with Article 47 (point (g)); affix the CE marking in accordance with Article 48 (point (h)); comply with the registration obligations referred to in Article 49(1) (point (i)); take the necessary corrective actions and provide the information required under Article 20 (point (j)); upon a reasoned request of a national competent authority, demonstrate conformity with the requirements of Section 2 (point (k)); and ensure the system complies with the accessibility requirements of Directives (EU) 2016/2102 and (EU) 2019/882 (point (l)).","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 16(a)-(l)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"editorial_interpretation","statement":"Article 16 reads like a table of contents and is therefore often planned as a single roadmap line. It is twelve separate duties with widely differing lead times: building a quality management system takes months, affixing a CE marking takes a day. The bigger trap sits in Article 25(1): anyone who puts their own brand on an existing high-risk system, substantially modifies it, or changes the intended purpose of a non-high-risk system so that it becomes high-risk counts as a provider and inherits all twelve points without ever having built anything. In the branding scenario of point (a) this applies without prejudice to contractual arrangements stipulating that the obligations are otherwise allocated, but you must have made and be able to show those arrangements in advance. In practice this catches parties that white-label AI or apply a general-purpose model to an Annex III use case.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 16(a)-(l)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"recommended_action","statement":"First determine whether you are a provider or whether Article 25 makes you one, then work out the twelve points as twelve separate work packages with an owner and a date. Start with points (c) and (f), because they set the lead time of the whole track.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 16(a)-(l)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}]}],"conditional":[{"slug":"article-61-informed-consent","id":"praxikon:eu:ai-act:obligation:article-61-informed-consent","label":"Article 61: informed consent of test subjects for testing in real world conditions","status":"possibly_applies","source_locator":"Article 60(4), point (i), with Article 61(1)","addressee":"reader","human_page":"https://www.praxikon.com/en/verplichtingen/article-61-informed-consent"}],"sources":[{"id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","title":"EU Artificial Intelligence Act 2024/1689","publisher":"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"},{"id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","title":"Digital Omnibus on AI 2026/1744","publisher":"European Parliament and Council","canonical_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj","source_version":"official-journal-2026-07-24","verified_at":"2026-08-08T00:00:00.000Z"},{"id":"praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines","title":"Draft guidelines on the classification of high-risk AI systems","publisher":"European Commission (AI Office)","canonical_url":"https://digital-strategy.ec.europa.eu/en/library/draft-commission-guidelines-classification-high-risk-ai-systems","eli":null,"source_version":"draft-for-consultation-2026-05-19","verified_at":"2026-08-08T00:00:00.000Z"},{"id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","title":"CEN-CENELEC JTC 21: European standards under standardisation request M/613","publisher":"CEN-CENELEC JTC 21","canonical_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null,"source_version":"work-programme-checked-2026-08-08","verified_at":"2026-08-08T00:00:00.000Z"},{"id":"praxikon:eu:ai-act:source:iso-iec-jtc1-sc42","title":"ISO/IEC JTC 1/SC 42: international standards for artificial intelligence","publisher":"ISO/IEC JTC 1/SC 42","canonical_url":"https://www.iso.org/committee/6794475.html","eli":null,"source_version":"catalogue-checked-2026-08-08","verified_at":"2026-08-08T00:00:00.000Z"}],"first_actions":[{"label":"Provide complete instructions for use","summary":"Describe capabilities, limitations, accuracy, oversight measures and expected lifetime in comprehensible form."},{"label":"Justify the Article 6(3) exception against each individual condition","summary":"Name which of the four Article 6(3) conditions you invoke, with facts, and separately justify why the system poses no significant risk of harm to health, safety or fundamental rights and does not materially influence the outcome of decision making."},{"label":"Complete the conformity route before market placement","summary":"Select the correct assessment procedure, draw up the EU declaration of conformity, affix the CE marking and register in the EU database."}],"evidence":[{"label":"Instructions and interpretation file","summary":"The received instructions for use plus their internal translation into work instructions per role.","url":null},{"label":"Article 49(2) registration record for the system assessed as not high-risk","summary":"Proof that the system for which you invoke the Article 6(3) exception is registered as Article 49(2) requires, with the registration number linked to the underlying assessment.","url":null},{"label":"Conformity file","summary":"The assessment, EU declaration of conformity, CE marking and registration proof, per system version.","url":null}],"guidance":[{"label":"Annex I lists legislation, not products","statement":"The draft guidelines of 19 May 2026, published for consultation and expressly non-binding, clarify that Annex I AI Act does not list individual products to be classified as high-risk, but Union harmonisation legislation regulating the safety aspects of certain products. Whether an AI system falls within the scope of Annex I therefore depends on whether the system, or the product of which it is a safety component, falls within the material scope of one of the listed legislative acts. According to the draft guidelines the list in Annex I is exhaustive; products can only be added or removed by amending the scope of the harmonisation legislation itself or by adding new harmonisation legislation to Annex I. The draft guidelines also state that through Article 6(1) the AI Act does not itself extend the scope of harmonisation legislation to new or additional products, and that the AI Act does not determine or change the risk profile of a product but builds on the sectoral risk classification. Products mentioned include machinery, toys, lifts, equipment and protective systems for potentially explosive atmospheres, radio equipment, pressure equipment, recreational craft, cableway installations, appliances burning gaseous fuels, medical devices, in vitro diagnostic medical devices, and products in the automotive and aviation sectors.","source_locator":"Draft guidelines Annex I, points (23) to (26)"},{"label":"Section A and Section B of Annex I trigger different requirement sets","statement":"The Commission draft guidelines of 19 May 2026, which are non-binding as long as the final version has not been adopted, draw a distinction that is often missed in practice. AI systems classified as high-risk under Article 6(1) in respect of products covered by the harmonisation legislation in Section A of Annex I are subject to the requirements for high-risk systems in Section 2 of Chapter III AI Act. By contrast, for AI systems classified as high-risk under Article 6(1) in respect of products covered by the harmonisation legislation in Section B of Annex I, only Article 6(1), Articles 102 to 109 and Article 112 AI Act apply. The draft guidelines refer to Article 2(2) AI Act for this. Section A contains harmonisation legislation based on the New Legislative Framework, Section B the other Union harmonisation legislation.","source_locator":"Draft guidelines Annex I, point (60), referring to Article 2(2) AI Act"},{"label":"Two cumulative conditions for high-risk under Annex I","statement":"The European Commission draft guidelines of 19 May 2026, which are expressly non-binding and not final, read Article 6(1) as two cumulative conditions. First, the AI system must be intended to be used as a safety component of a product, or the AI system must itself be a product, covered by the Union harmonisation legislation listed in Annex I. Second, that product, or the AI system itself where it is the product, must be required to undergo a third-party conformity assessment. The draft guidelines state explicitly that not all AI systems that are components of regulated products are high-risk, but only the subset that satisfies both criteria.","source_locator":"Draft guidelines Annex I, points (27) and (21)"},{"label":"The Article 6(3) filter: four exhaustive grounds, to be read narrowly","statement":"According to the non-binding draft guidelines of 19 May 2026 on the classification of high-risk AI, Article 6(3) sets out four grounds on which a provider may exempt a system from high-risk classification: performing a narrow procedural task, improving the result of a previously completed human activity, detecting decision-making patterns or deviations from prior patterns without replacing or influencing the previously completed human assessment absent proper human review, and performing a preparatory task. Paragraph (88) of this draft states these grounds are exhaustive but alternative, that there is no separate independent risk test, and that they must be interpreted narrowly because Article 6(3) is an exception to rules that among other things protect fundamental rights. Paragraph (87) states the filter applies only to systems under Article 6(2) and not to systems under Article 6(1). Paragraph (89) states a system always remains high-risk where it performs profiling. Paragraph (90) adds that the filter does not apply where the system forms part of a complex system whose combined intended purpose or joint outputs materially influence an individual decision, including agentic AI. Paragraphs (113) to (116) of this draft describe that this is a self-assessment by the provider, that Article 6(4) requires documenting the assessment before placing on the market and registering in the Article 71 EU database, and that the assessment must contain at least the intended purpose, why the system falls under Article 6(2), which Article 6(3) condition applies and why, and why the system does not perform profiling. Paragraph (117) of these draft guidelines points to Articles 80 and 99 where an authority finds a system was misclassified as non high-risk to circumvent the rules.","source_locator":"Draft guidelines on high-risk AI classification (19 May 2026), Annex III chapter, sections 2.7, 2.7.1, 2.7.3 and 2.7.4, paragraphs (84) to (90) and (113) to (117)"}],"examples":[{"label":"Candidate recommendation that automatically becomes a decision","situation":"An employer uses a system that ranks applicants and recommends a candidate to hire. In one setup a recruiter weighs that recommendation in their own assessment; in the other the outcome is applied automatically and a candidate is rejected without anyone looking at it.","outcome":"The Commission draft guidelines of 19 May 2026 address this case when determining whether an application falls under Annex III. The document is a consultation version: non-binding and not yet final.","lesson":"Assess a recruitment system on its intended purpose rather than on whether a recruiter reviews the output, because adding or removing human involvement does not change its high-risk classification.","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III","provenance":"official"},{"label":"Face comparison at the border gate: verification or identification","situation":"An automated border gate uses biometric facial recognition to compare a traveller’s face with the photo in the passport chip. The same camera could technically also compare against a law-enforcement database, and exactly that difference decides whether this biometrics is high-risk.","outcome":"The Commission draft guidelines of 19 May 2026 state that biometric verification falls outside the high-risk classification: one-to-one comparison of presented biometrics with previously stored biometrics, for the sole purpose of confirming that a person is who they claim to be. Where the same capture is additionally compared against a law-enforcement database, it does become remote biometric identification. The document is a consultation version: non-binding and not yet final.","lesson":"Test your biometric application on purpose rather than technology: the same camera and the same model stay outside the high-risk route as long as the comparison is one-to-one and only confirms identity, and fall inside it as soon as that same capture is also held against a database. Record per application what the comparison runs against, because that single design choice moves the entire regime.","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III, paragraph (136)","provenance":"official"},{"label":"A CV filter that ranks applicants","situation":"An employer has an external recruitment system score and rank every incoming application, after which recruiters only review the top twenty percent by hand. The vendor puts the system on the market under its own name, and the employer uses it in its own selection process.","outcome":"The Commission draft guidelines of 19 May 2026 address this case when determining whether an application falls under Annex III. The document is a consultation version: non-binding and not yet final.","lesson":"Recruiters keeping the final say does not help you, because once the system scores or ranks applicants and thereby shapes the shortlist it stays high-risk and no exemption applies.","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III","provenance":"official"},{"label":"Application file handling at an educational institution","situation":"An educational institution uses AI for application file handling: indexing, searching, text and speech processing, translation of documents submitted with applications, and extracting, transforming and organising the collected data into a usable format.","outcome":"The Commission draft guidelines of 19 May 2026 address this case when determining whether an application falls under Annex III. The document is a consultation version: non-binding and not yet final.","lesson":"Indexing, searching, translating and reorganising application files remains preparatory work, as long as the system leaves the substantive judgment on the application entirely to the institution.","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III","provenance":"official"}],"standards":[{"label":"ISO/IEC 12792: transparency taxonomy of AI systems","summary":"The international taxonomy of transparency information elements, usable as a checklist for the Article 13 instructions for use.","statement":"ISO/IEC 12792:2025 (Information technology: Artificial intelligence: Transparency taxonomy of AI systems) was published in November 2025 by ISO/IEC JTC 1/SC 42. It specifies a taxonomy of information elements to help stakeholders identify and address transparency needs, and describes the semantics of those elements and their relevance to different stakeholders' objectives. The text was adopted as a European standard as EN ISO/IEC 12792:2025. It is not cited in the Official Journal and therefore confers no presumption of conformity under Article 40. For Article 13 the designated deliverable is prEN 18229-3."},{"label":"prEN 18285: conformity assessment framework for AI systems","summary":"The draft European standard operationalising the conformity assessment procedure of Article 43 and Annex VII.","statement":"prEN 18285 (Conformity assessment framework) is the JTC 21 deliverable under M/613 covering the conformity assessment of high-risk AI systems under Article 43 and Annex VII of the AI Act. As at June 2026 the deliverable was at the drafting stage. It has not yet been published as an EN and is not cited in the Official Journal. Standardisation request M/613 was amended by Implementing Decision C(2025)3871 of 23 June 2025 and expires on 28 February 2027."}],"definitions":[],"answer_page":"https://www.praxikon.com/en/antwoord/instructies-voor-gebruik","follow_up_questions":[{"question":"What technical documentation does the AI Act require (Article 11)?","url":"https://www.praxikon.com/en/antwoord/technische-documentatie"},{"question":"How do conformity assessment and CE marking work for AI?","url":"https://www.praxikon.com/en/antwoord/conformiteitsbeoordeling-ce"},{"question":"We use AI in healthcare. Which AI Act rules apply there?","url":"https://www.praxikon.com/en/antwoord/zorg-medische-ai"}],"disclaimer":"General interpretation, not legal advice. The official source remains authoritative.","methodology":"https://www.praxikon.com/en/methodologie"}