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Effective oversight requires understanding, time and mandate, which ties directly into the Article 4 literacy measures.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 14(1)-(5)","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":"Appoint the overseeing persons per (upcoming) high-risk system now, train them specifically and record their mandate to intervene in writing.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 14(1)-(5)","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":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-14-human-oversight","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 14 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"id":"raip:obligation:article-15-accuracy-robustness","type":"obligation","slug":"article-15-accuracy-robustness","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"199a0d927cd87d8f645eb626e7dee2689ec36c5580b02d3ae5825e7723a243ce","label":"Article 15: accuracy, robustness and cybersecurity","summary":"Appropriate levels of performance, robustness and security across the lifecycle of high-risk AI.","topics":["high-risk-requirements"],"actor_ids":["raip:actor:provider"],"obligation_ids":[],"change_ids":[],"action_ids":["raip:action:article-15-accuracy-robustness-act"],"evidence_ids":["raip:evidence:article-15-accuracy-robustness-record"],"control_ids":["raip:control:article-15-accuracy-robustness-control"],"template_ids":["raip:template:article-15-accuracy-robustness-legal-text"],"conditions":[{"id":"article-15-accuracy-robustness-scope","operator":"all","description":"The provider places a high-risk AI system on the market or puts it into service."}],"exceptions":[{"id":"article-15-accuracy-robustness-exception","operator":"not","description":"Systems that continue learning after deployment carry additional requirements to control feedback loops and drift."}],"statements":[{"kind":"official_fact","text":"Article 15 requires high-risk systems to achieve and maintain appropriate levels of accuracy, robustness and cybersecurity throughout the lifecycle, including resilience against errors and AI-specific attacks such as data poisoning and adversarial examples.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 15(1)-(5)","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":"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.","citations":[{"source_id":"raip: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"}],"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":"Accuracy here is not a marketing number but a declared, testable value stated in the instructions for use and held against you in production.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 15(1)-(5)","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":"Ask suppliers now for declared accuracy levels and test reports, and set up production monitoring against those levels.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 15(1)-(5)","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":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-15-accuracy-robustness","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 15 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"id":"raip:obligation:article-16-provider-obligations","type":"obligation","slug":"article-16-provider-obligations","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"ea012b91355e14a36ed8675db39e3f92b8504612ec523c3942adbf10c2e2933b","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.","topics":["high-risk-requirements"],"actor_ids":["raip:actor:provider"],"obligation_ids":[],"change_ids":[],"action_ids":["raip:action:assign-article-16-provider-duties"],"evidence_ids":["raip:evidence:article-16-provider-dossier"],"control_ids":["raip:control:article-16-pre-market-release-gate"],"template_ids":["raip:template:article-16-provider-obligations-legal-text"],"conditions":[{"id":"article-16-provider-obligations-scope","operator":"all","description":"Applies to providers of high-risk AI systems. 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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)).","citations":[{"source_id":"raip: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"}],"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":"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.","citations":[{"source_id":"raip: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"}],"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":"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.","citations":[{"source_id":"raip: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"}],"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":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-16-provider-obligations","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 16 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"id":"raip:obligation:article-17-quality-management","type":"obligation","slug":"article-17-quality-management","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"a9108c063d5e7bbad1206d3065fe3f4639017fcfd6fa99929ca8414e4e6f4fa2","label":"Article 17: quality management system","summary":"The documented quality system through which a high-risk AI provider structurally assures compliance.","topics":["high-risk-requirements"],"actor_ids":["raip:actor:provider"],"obligation_ids":[],"change_ids":[],"action_ids":["raip:action:article-17-quality-management-act"],"evidence_ids":["raip:evidence:article-17-quality-management-record"],"control_ids":["raip:control:article-17-quality-management-control"],"template_ids":["raip:template:article-17-quality-management-legal-text"],"conditions":[{"id":"article-17-quality-management-scope","operator":"all","description":"The provider places high-risk AI systems on the market or puts them into service."}],"exceptions":[{"id":"article-17-quality-management-exception","operator":"not","description":"Providers already under sectoral quality regimes may integrate the AI elements into that existing system; SMEs may implement elements in simplified form."}],"statements":[{"kind":"official_fact","text":"Article 17 requires a documented quality management system covering a compliance strategy, design and development procedures, data management, risk management, post-market monitoring, incident reporting and an accountability structure.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 17(1)-(3)","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":"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.","citations":[{"source_id":"raip: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"}],"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":"The QMS is the umbrella over all other provider duties: those with the separate files but no system connecting them fail exactly this article in an audit.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 17(1)-(3)","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":"Build the QMS not as a separate document but as an index on top of the existing files (risk, data, documentation, monitoring) with owners per procedure.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 17(1)-(3)","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":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-17-quality-management","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 17 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"id":"raip:obligation:article-4-ai-literacy","type":"obligation","slug":"article-4-ai-literacy","version":"2.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"663d3c7e7b6ad56fd59f5421dc6d955c88154fbcbe09c7972f6aab14f89d6ca0","label":"Article 4: AI literacy","summary":"Providers and deployers take measures that support the development of AI literacy.","topics":["ai-literacy"],"actor_ids":["raip:actor:deployer","raip:actor:provider"],"obligation_ids":[],"change_ids":[],"action_ids":["raip:action:article-4-measures"],"evidence_ids":["raip:evidence:article-4-measures-record"],"control_ids":["raip:control:article-4-periodic-review"],"template_ids":["raip:template:article-4-measures-plan"],"conditions":[{"id":"article-4-in-scope-ai","operator":"all","description":"The organisation is a provider or deployer of an AI system within scope."}],"exceptions":[{"id":"article-4-no-specific-level","operator":"not","description":"The provision does not require a specific individual level to be guaranteed."}],"statements":[{"kind":"official_fact","text":"Since 27 July 2026, providers and deployers must take measures supporting the development of AI literacy. The provision does not require a guaranteed individual level.","citations":[{"source_id":"raip:source:reg-eu-2026-1744","source_locator":"Amendment of Article 4; entry into force 27 July 2026","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/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":"Evidence is primarily a proportionate record of measures by role and context, not one prescribed course or certificate.","citations":[{"source_id":"raip:source:commission-ai-literacy-qa","source_locator":"Questions on measures, formats, certificates and records","source_url":"https://digital-strategy.ec.europa.eu/en/faqs/ai-literacy-questions-answers","eli":null}],"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":"Inventory roles and AI systems, select appropriate measures and record the choice, implementation and periodic review.","citations":[{"source_id":"raip:source:commission-ai-literacy-qa","source_locator":"Implementation examples and evidence guidance","source_url":"https://digital-strategy.ec.europa.eu/en/faqs/ai-literacy-questions-answers","eli":null}],"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":"2025-02-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-4-ai-literacy","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","label":"Official amending regulation"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"id":"raip:obligation:article-5-prohibited-practices","type":"obligation","slug":"article-5-prohibited-practices","version":"1.0.0","effective_at":"2025-02-02T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"2a304e57420ddb3e1168471bacc472440d24510c30df67f2d5c57b7b7b921f60","label":"Article 5: prohibited practices","summary":"The prohibition of AI practices carrying unacceptable risk, such as manipulation, social scoring and certain biometric applications.","topics":["prohibited-practices"],"actor_ids":["raip:actor:deployer","raip:actor:provider"],"obligation_ids":[],"change_ids":[],"action_ids":["raip:action:article-5-screen"],"evidence_ids":["raip:evidence:article-5-screening-record"],"control_ids":["raip:control:article-5-intake-gate"],"template_ids":["raip:template:article-5-legal-text"],"conditions":[{"id":"article-5-listed-practice","operator":"any","description":"Placing on the market, putting into service or using AI falls under one of the practices in Article 5(1), including harmful manipulation or exploitation of vulnerabilities, social scoring, predicting criminal offences based on profiling, untargeted scraping of facial images, emotion recognition in the workplace or education, biometric categorisation by sensitive characteristics and real-time remote biometric identification in publicly accessible spaces for law enforcement."}],"exceptions":[{"id":"article-5-narrow-exceptions","operator":"not","description":"The exceptions are narrow: among others, emotion recognition for medical or safety reasons, and the exhaustively defined law-enforcement situations with authorisation for real-time remote biometric identification in Article 5(2) to (7). The exception must be established and documented in advance."}],"statements":[{"kind":"official_fact","text":"The prohibited practices of Article 5 apply since 2 February 2025 and are the only AI Act category enforceable for that entire period. Violations carry the highest fine ceiling in the regulation: up to 35 million euro or 7 percent of worldwide annual turnover.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 5, Article 99(3) and Article 113(a)","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":"The Digital Omnibus adds a prohibition on AI for child sexual abuse material and non-consensual intimate synthetic content; the accompanying technical safeguards are required by 2 December 2026.","citations":[{"source_id":"raip:source:reg-eu-2026-1744","source_locator":"Amendment to Article 5 and transition to 2 December 2026","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/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":"The line often sits in the definitional details: the same technique can be prohibited in the workplace and permitted in another context. Screen per concrete use and context, not per technology, and do so before procurement or go-live.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 5(1)(a)-(h)","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":"Make the Article 5 screening the first step of every classification and record the outcome per system in the register, including the reasoning why a practice does not fall under the prohibition.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 5 read with Article 6 classification order","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":"2025-02-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-5-prohibited-practices","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 5 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"id":"raip:obligation:article-50-transparency","type":"obligation","slug":"article-50-transparency","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"e7d9642df4fcfcc22b3123056ae8c3dda7e29f776702c8b55543907c38e70a62","label":"Article 50: transparency","summary":"Specific disclosure, marking and labelling duties for certain AI systems and synthetic content.","topics":["transparency"],"actor_ids":["raip:actor:deployer","raip:actor:provider"],"obligation_ids":[],"change_ids":[],"action_ids":["raip:action:article-50-disclosure"],"evidence_ids":["raip:evidence:article-50-implementation-record"],"control_ids":["raip:control:article-50-release-check"],"template_ids":["raip:template:article-50-checklist"],"conditions":[{"id":"article-50-direct-interaction","operator":"any","description":"An AI system is intended to interact directly with natural persons."},{"id":"article-50-synthetic-content","operator":"any","description":"The system generates or manipulates synthetic audio, image, video or text, or the use concerns a specifically listed deployer scenario."}],"exceptions":[{"id":"article-50-obvious-interaction","operator":"not","description":"The direct-interaction disclosure is not required where this is obvious to a reasonably well-informed, observant and circumspect person, considering circumstances and context."},{"id":"article-50-legacy-marking-grace","operator":"not","description":"Only Article 50(2) has a transition until 2 December 2026 for systems placed on the market before 2 August 2026."}],"statements":[{"kind":"official_fact","text":"Article 50 applies since 2 August 2026. The precise duty differs by scenario: direct AI interaction, machine-readable marking, emotion recognition or biometric categorisation, deepfakes and certain public-interest text.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 50(1)-(5) and Article 113","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":"A generic rule that all AI content must always carry a visible label is too broad. First classify the specific Article 50 scenario.","citations":[{"source_id":"raip:source:commission-article-50-guidelines","source_locator":"Final guidelines, scope by Article 50 paragraph","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"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":"For each system, record the applicable paragraph, responsible actor, implemented disclosure or marking and how it was tested.","citations":[{"source_id":"raip:source:commission-article-50-guidelines","source_locator":"Implementation guidance for providers and deployers","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"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","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-50-transparency","label":"Open the human explanation"},{"relation":"official_source","href":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","label":"Final Commission guidelines"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"id":"raip:obligation:article-57-regulatory-sandboxes","type":"obligation","slug":"article-57-regulatory-sandboxes","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"78a4384fc62142d6d79beaf2c2d90e69df0dab7f8521a5dd1786123db6470ce7","label":"Article 57: AI regulatory sandboxes","summary":"Member States must provide at least one national AI regulatory sandbox. For you this is a voluntary route: you develop, train, test and validate an innovative AI system in a controlled, supervised environment under a plan agreed with the competent authority, before placing it on the market or putting it into service.","topics":["innovation"],"actor_ids":["raip:actor:deployer","raip:actor:provider","raip:actor:public-law-body"],"obligation_ids":[],"change_ids":[],"action_ids":["raip:action:article-57-sandbox-application-and-plan"],"evidence_ids":["raip:evidence:article-57-written-proof-and-exit-report"],"control_ids":["raip:control:article-57-sandbox-supervision-and-fine-shield"],"template_ids":["raip:template:article-57-regulatory-sandboxes-legal-text"],"conditions":[{"id":"article-57-regulatory-sandboxes-scope","operator":"all","description":"Relevant where you are a provider or prospective provider of an innovative AI system that you want to develop, train, test or validate before placing it on the market or putting it into service, and you want up-front certainty about classification or about how you meet the requirements of this Regulation."}],"exceptions":[{"id":"article-57-regulatory-sandboxes-exception","operator":"not","description":"Participation is voluntary. Article 57 places the duty on the Member State to provide a sandbox, not on you to join one. A Member State may also fulfil that duty by participating in an existing sandbox with equivalent national coverage. Article 57(4) leaves other regulatory sandboxes established under Union or national law unaffected."}],"statements":[{"kind":"official_fact","text":"Article 57(1) requires Member States to ensure that their competent authorities establish at least one AI regulatory sandbox at national level. The text of Regulation (EU) 2024/1689 as published in the Official Journal provides that the sandbox shall be operational by 2 August 2026, and that wording still stands unchanged on 9 August 2026 in the article text published by the European Commission. The timeline the European Commission publishes after the Digital Omnibus, Regulation (EU) 2026/1744, entered into force on 27 July 2026 places the milestone at 2 August 2027 instead, stating \"Member States should have at least one AI regulatory sandbox per country operational\". The consolidated text of Article 57(1) after the Omnibus has not been verified at article level; rely on the consolidated version on EUR-Lex for the exact date. Chapter VI, which contains Article 57, is not among the exceptions in Article 113 and therefore applies since 2 August 2026. Article 57(1) further provides that the obligation may also be fulfilled by participating in an existing sandbox, in so far as that participation provides an equivalent level of national coverage. Article 57(5) defines the sandbox as a controlled environment that fosters innovation and facilitates the development, training, testing and validation of innovative AI systems for a limited time, pursuant to a specific sandbox plan agreed between the provider or prospective provider and the competent authority, before the system is placed on the market or put into service. Such sandboxes may include testing in real world conditions supervised therein. Article 57(15) requires the AI Office to make publicly available, and keep up to date, a list of planned and existing sandboxes.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 57(1)-(17), Article 58, Article 113; as amended by Regulation (EU) 2026/1744","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":"The common mistake is to read the sandbox as a delay or an exemption. It is neither. Article 57(11) leaves the competent authority's supervisory and corrective powers fully intact and expressly empowers it to suspend your testing or your participation, temporarily or permanently, where risks cannot be effectively mitigated. A sandbox is useful for exactly one profile: you are building an AI system that is likely to fall under Annex III, you are uncertain about its classification or about how to meet Chapter III, Section 2, and you want that uncertainty resolved before you go to market. If you are purely a deployer buying a system, the sandbox is not your route: at most you can join as a partner of the provider under Article 58(2), point (b). Second trap: 2 August 2027 is a duty on the Member State, not on you. The date on this item is therefore 2 August 2026: from that moment Chapter VI applies and the route is open to you. You cannot hang your own preparation on that date, and the date says nothing about whether your national sandbox will actually have capacity by then. Third trap: people confuse the Article 57 sandbox with Article 60 real-world testing. These are two distinct routes with different conditions. Real-world testing can take place inside the sandbox (Article 57(5) and Article 58(4)) or outside it under Article 60, and the safeguards differ.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 57(1)-(17), Article 58, Article 113; as amended by Regulation (EU) 2026/1744","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":"First establish your role: only providers and prospective providers can enter on their own. Then use the AI Office's published list of planned and existing sandboxes (Article 57(15)) to find the sandbox open to you, in your Member State or jointly with others. Before you apply, state exactly which uncertainty you want resolved, ideally focused on classification under Article 6 or on a specific requirement in Chapter III, Section 2. Plan for the three-month decision period that Article 58(2), point (a), requires the implementing acts to ensure, build it into your product timeline, and ask the competent authority in writing which period it currently applies. On entry, record in writing what the sandbox plan covers, and on exit request both the written proof and the exit report.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 57(1)-(17), Article 58, Article 113; as amended by Regulation (EU) 2026/1744","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","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-57-regulatory-sandboxes","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 57 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"id":"raip:obligation:article-60-real-world-testing","type":"obligation","slug":"article-60-real-world-testing","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"bf71337c2ed2905eb1e26dce39b21be79311db228fa3f7c6782c129fffc241db","label":"Article 60: testing in real world conditions outside a sandbox","summary":"If you want to test an Annex III high-risk AI system with real people and real outcomes before placing it on the market, a full regime applies: a plan, prior approval by the market surveillance authority, registration, informed consent and a maximum duration.","topics":["innovation"],"actor_ids":["raip:actor:deployer","raip:actor:provider"],"obligation_ids":[],"change_ids":[],"action_ids":["raip:action:article-60-testing-plan-and-authorisation"],"evidence_ids":["raip:evidence:article-61-informed-consent-record"],"control_ids":["raip:control:article-60-oversight-and-incident-response"],"template_ids":["raip:template:article-60-real-world-testing-legal-text"],"conditions":[{"id":"article-60-real-world-testing-scope","operator":"all","description":"Applies where you are a provider or prospective provider of an Annex III high-risk AI system and you want to test it in real world conditions outside an AI regulatory sandbox, before placing it on the market or putting it into service. If you are established outside the Union, Article 60(4), point (d), requires you to appoint a legal representative established in the Union; that is a different figure from the authorised representative under Article 22."}],"exceptions":[{"id":"article-60-real-world-testing-exception","operator":"not","description":"Article 60(1), third subparagraph, leaves Union and national law on real-world testing of high-risk systems related to products under the Annex I harmonisation legislation unaffected. Article 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the system from being tested, testing may proceed without consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test. For the systems referred to in Annex III, points 1, 6 and 7, in law enforcement, migration, asylum and border control, registration runs through the secure non-public section of the EU database under Article 49(4), point (d). For the systems referred to in Annex III, point 2, Article 49(5) requires registration at national level."}],"statements":[{"kind":"official_fact","text":"Article 60(1) provides that testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes may be conducted by providers or prospective providers of high-risk AI systems listed in Annex III, in accordance with that Article and the real-world testing plan, without prejudice to the prohibitions under Article 5. The Commission specifies the detailed elements of that plan by implementing act. The third subparagraph of paragraph 1 provides that the paragraph is without prejudice to Union or national law on the testing in real world conditions of high-risk AI systems related to products covered by the Union harmonisation legislation listed in Annex I. Article 60(2) allows providers or prospective providers to test at any time before placing on the market or putting into service, on their own or in partnership with one or more deployers or prospective deployers. Article 60(3) provides that such testing is without prejudice to any ethical review required by Union or national law. Article 60(4), point (f), caps the duration: no longer than necessary to achieve its objectives and in any case no longer than six months, which may be extended by an additional six months subject to prior notification to the market surveillance authority with an explanation of the need. Article 60(4), point (g), requires that subjects belonging to vulnerable groups due to age or disability are appropriately protected. Article 60(9) expressly states that the provider or prospective provider remains fully subject to applicable Union and national law on any damage caused in the course of their testing in real world conditions. Chapter VI, which contains Article 60, is not among the exceptions in Article 113 and applies since 2 August 2026.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 60(1)-(4), Article 60(9), Article 113","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":"Many organisations call what they do a pilot and assume that keeps them outside the Regulation. Article 60 shows that this does not hold once you test an Annex III system in real world conditions with real people and real outcomes. A full regime then applies: a plan, prior approval, registration with a Union-wide unique single identification number, informed consent, and a hard six-month clock with a maximum six-month extension. The heaviest requirement in practice is Article 60(4), point (k): the predictions, recommendations or decisions of the system must be capable of being effectively reversed and disregarded. If you are testing a selection, scoring or triage system whose output feeds straight into the workflow with nobody able to reverse it, your design does not qualify, however careful your consent form is. Note the timing too, because it is commercially interesting. Chapter VI applies since 2 August 2026, while the core obligations for standalone Annex III systems only apply from 2 December 2027. The testing route is therefore open before the requirements themselves bite, and that is exactly the window in which to validate your design rather than rebuild it later. Finally, Article 60(3) leaves any ethical review required under other law fully in place, and Article 60(9) expressly states that you remain fully subject to the applicable law on damage caused during the testing.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 60(1)-(4), Article 60(9), Article 113","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":"Inventory which running or planned trials are in fact real-world testing: real users, real data, outputs that feed into the workflow. Test those first against Article 60(4), point (k): can the output genuinely be reversed and disregarded? If not, redesign the trial before you submit anything. Then choose deliberately between two routes: supervised testing inside a sandbox under Article 57(5) and Article 58(4), or outside a sandbox under Article 60. Plan the six months realistically and decide in advance at which point you will request an extension, since that requires prior notification with a reasoned explanation. Check whether an ethical review is mandatory in your domain and start it in parallel, because Article 60(3) does not exempt you from it.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 60(1)-(4), Article 60(9), Article 113","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","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-60-real-world-testing","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 60 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"id":"raip:obligation:article-72-post-market-monitoring","type":"obligation","slug":"article-72-post-market-monitoring","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"d8e7583b07de3486f3d47e53770d4476efd6059e27607646ed078f19258dcf4d","label":"Article 72: post-market monitoring","summary":"Systematic monitoring of high-risk AI in real use, after market placement.","topics":["post-market"],"actor_ids":["raip:actor:deployer","raip:actor:provider"],"obligation_ids":[],"change_ids":[],"action_ids":["raip:action:article-72-post-market-monitoring-act"],"evidence_ids":["raip:evidence:article-72-post-market-monitoring-record"],"control_ids":["raip:control:article-72-post-market-monitoring-control"],"template_ids":["raip:template:article-72-post-market-monitoring-legal-text"],"conditions":[{"id":"article-72-post-market-monitoring-scope","operator":"all","description":"The provider has a high-risk system on the market; deployers supply the real-world data via monitoring and signals."}],"exceptions":[{"id":"article-72-post-market-monitoring-exception","operator":"not","description":"The plan may be proportionate to the nature of the system and align with existing sectoral monitoring regimes."}],"statements":[{"kind":"official_fact","text":"Article 72 obliges providers to operate a post-market monitoring system with a plan forming part of the technical documentation, collecting relevant real-world data to evaluate continued compliance with Section 2.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 72(1)-(4)","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":"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.","citations":[{"source_id":"raip: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"}],"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":"Compliance does not stop at go-live: this article turns compliance into a continuous state. For deployers it is also the basis to force suppliers to act on deviations.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 72(1)-(4)","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":"Design the monitoring together with the Article 12 logging: the same data flows feed both duties.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 72(1)-(4)","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":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-72-post-market-monitoring","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 72 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"id":"raip:obligation:article-73-incident-reporting","type":"obligation","slug":"article-73-incident-reporting","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"f9be2f643e299eb2a89489835be1d628f5cc4919662f21ab2f1950d58f6c1cd8","label":"Article 73: serious incident reporting","summary":"The duty to report serious incidents with high-risk AI, under strict deadlines.","topics":["post-market"],"actor_ids":["raip:actor:deployer","raip:actor:provider"],"obligation_ids":[],"change_ids":[],"action_ids":["raip:action:article-73-incident-reporting-act"],"evidence_ids":["raip:evidence:article-73-incident-reporting-record"],"control_ids":["raip:control:article-73-incident-reporting-control"],"template_ids":["raip:template:article-73-incident-reporting-legal-text"],"conditions":[{"id":"article-73-incident-reporting-scope","operator":"all","description":"A serious incident occurs with a high-risk system: death or serious harm to health, serious and irreversible disruption of critical infrastructure, infringement of fundamental-rights protections or serious damage to property or environment."}],"exceptions":[{"id":"article-73-incident-reporting-exception","operator":"not","description":"For systems under sectoral reporting regimes with equivalent duties, reporting may run through that regime to avoid duplication."}],"statements":[{"kind":"official_fact","text":"Article 73 obliges providers to report serious incidents to the market surveillance authority: immediately after establishing the causal link and at the latest within 15 days, shortened to 10 days in the event of death and to 2 days for widespread infringement or serious disruption of critical infrastructure. Deployers inform the provider without delay.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 73(1)-(11)","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":"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.","citations":[{"source_id":"raip: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"}],"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":"The deadlines are too short to design the process during the incident: those who decide who reports at the first incident will not make 15 days, let alone 2. This is the GDPR breach playbook, but for AI.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 73(1)-(11)","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":"Connect the AI incident process to the existing breach and security process and add the AI-specific definitions and deadlines.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 73(1)-(11)","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":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-73-incident-reporting","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 73 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"id":"raip:obligation:article-9-risk-management","type":"obligation","slug":"article-9-risk-management","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"6e7b0b975955f2385aee7f2fd811e20774c496a22f35143857e3c97b2e792611","label":"Article 9: risk management system","summary":"A continuous, documented risk management system across the entire lifecycle of a high-risk AI system.","topics":["high-risk-requirements"],"actor_ids":["raip:actor:provider"],"obligation_ids":[],"change_ids":[],"action_ids":["raip:action:article-9-risk-management-act"],"evidence_ids":["raip:evidence:article-9-risk-management-record"],"control_ids":["raip:control:article-9-risk-management-control"],"template_ids":["raip:template:article-9-risk-management-legal-text"],"conditions":[{"id":"article-9-risk-management-scope","operator":"all","description":"The system is high-risk under Article 6 and the provider places it on the market or puts it into service."}],"exceptions":[{"id":"article-9-risk-management-exception","operator":"not","description":"Risks arising only from misuse beyond any reasonably foreseeable use fall outside the mandatory scope."}],"statements":[{"kind":"official_fact","text":"Article 9 requires a risk management system as a continuous, iterative process across the entire lifecycle, with identification, analysis, evaluation and mitigation of risks to health, safety and fundamental rights, and testing to determine the most appropriate measures.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 9(1)-(10)","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":"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.","citations":[{"source_id":"raip: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"}],"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 not a one-off risk analysis but a living process: most organisations have an assessment, but no cycle that reruns on every change. The cycle is what a supervisor will request.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 9(1)-(10)","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":"Start the risk management file now for systems that will become high-risk towards 2 December 2027: today’s design and procurement choices determine tomorrow’s residual risks.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Article 9(1)-(10)","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":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-9-risk-management","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 9 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"id":"raip:obligation:conformity-ce-registration","type":"obligation","slug":"conformity-ce-registration","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"f261f03efe201a9b10f7fb4c76b29866cdbe28d0b46f2d4a93b807ec74a94366","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.","topics":["conformity"],"actor_ids":["raip:actor:provider","raip:actor:public-law-body"],"obligation_ids":[],"change_ids":[],"action_ids":["raip:action:conformity-ce-registration-act"],"evidence_ids":["raip:evidence:conformity-ce-registration-record"],"control_ids":["raip:control:conformity-ce-registration-control"],"template_ids":["raip:template:conformity-ce-registration-legal-text"],"conditions":[{"id":"conformity-ce-registration-scope","operator":"all","description":"The provider places a high-risk system on the market; public deployers also register their use."}],"exceptions":[{"id":"conformity-ce-registration-exception","operator":"not","description":"For most Annex III systems internal control suffices (Annex VI); a notified body is required for certain biometrics and where harmonised standards are lacking."}],"statements":[{"kind":"official_fact","text":"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.","citations":[{"source_id":"raip: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"}],"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":"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.","citations":[{"source_id":"raip: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"}],"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":"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.","citations":[{"source_id":"raip: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"}],"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":"Plan the conformity route backwards from 2 December 2027: standards selection, assessment, declaration and registration together take months, not weeks.","citations":[{"source_id":"raip: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"}],"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":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/conformity-ce-registration","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 43-49 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"id":"raip:obligation:value-chain-representative","type":"obligation","slug":"value-chain-representative","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"95c7f6d3b769013104433431e2d023f26c1961bfa68fd406e6ac5814a9db4865","label":"Articles 22-25: value chain and authorised representative","summary":"Role shifts in the AI value chain and the mandatory representative for non-EU providers.","topics":["value-chain"],"actor_ids":["raip:actor:deployer","raip:actor:provider"],"obligation_ids":[],"change_ids":[],"action_ids":["raip:action:value-chain-representative-act"],"evidence_ids":["raip:evidence:value-chain-representative-record"],"control_ids":["raip:control:value-chain-representative-control"],"template_ids":["raip:template:value-chain-representative-legal-text"],"conditions":[{"id":"value-chain-representative-scope","operator":"all","description":"A high-risk system is supplied, modified, rebranded or placed on the Union market from outside the EU."}],"exceptions":[{"id":"value-chain-representative-exception","operator":"not","description":"Those acting solely as distributor or importer without the Article 25 triggers remain in that lighter role, with their own verification duties."}],"statements":[{"kind":"official_fact","text":"Article 25 provides that a distributor, importer, deployer or third party becomes the provider when it puts its name on a high-risk system, substantially modifies it or changes its intended purpose so it becomes high-risk; Article 22 obliges third-country providers to appoint a written authorised representative in the Union.","citations":[{"source_id":"raip:source:reg-eu-2024-1689","source_locator":"Articles 22 and 25","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":"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.","citations":[{"source_id":"raip: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"}],"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":"The most dangerous role switch is the unintended one: your own layer on top of a procured model, your own brand on a tool, and you suddenly carry the full provider duties. 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