{"answer_id":"praxikon:eu:ai-act:answer:conformiteitsbeoordeling-ce","canonical_page":"https://www.praxikon.com/en/antwoord/conformiteitsbeoordeling-ce","query":"How do conformity assessment and CE marking work for AI?","lang":"en","view":"full","mode":"scenario","question":"How do conformity assessment and CE marking work for AI?","situation":"You want to know when an AI system needs a conformity assessment and CE marking and who performs it.","likely_role":"Provider (the deployer checks for it when buying)","note":"High-risk AI undergoes a conformity assessment before market placement and then carries a CE marking. For most Annex III systems this runs via the provider’s internal control; for certain biometrics and for AI in regulated products a notified body is involved. The duty follows the timeline: Annex III from 2 December 2027, Annex I from 2 August 2028. For buyers: ask your supplier for it.","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":"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":"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":"article-20-corrective-actions","label":"Article 20: corrective actions and duty of information","summary":"A provider that considers, or has reason to consider, that a high-risk AI system it has placed on the market or put into service is not in conformity with the Regulation must immediately take the necessary corrective actions and inform the distributors accordingly, and, where applicable, also the deployers, the authorised representative and the importers. Where that system also presents a risk within the meaning of Article 79(1), the provider must immediately investigate the causes and inform the competent market surveillance authorities and, where applicable, the notified body that issued a certificate under Article 44.","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-20-corrective-actions","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. Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system that they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective actions to bring that system into conformity, to withdraw it, to disable it, or to recall it, as appropriate. They shall inform the distributors of the high-risk AI system concerned and, where applicable, the deployers, the authorised representative and importers accordingly. Paragraph 2. Where the high-risk AI system presents a risk within the meaning of Article 79(1) and the provider becomes aware of that risk, it shall immediately investigate the causes, in collaboration with the reporting deployer, where applicable, and inform the market surveillance authorities competent for the high-risk AI system concerned and, where applicable, the notified body that issued a certificate for that high-risk AI system in accordance with Article 44, in particular, of the nature of the non-compliance and of any relevant corrective action taken.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 20(1)-(2)","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":"Article 1, point (40)(b), of Regulation (EU) 2026/1744, replacing Article 113, third paragraph, point (c), of Regulation (EU) 2024/1689","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":"This provision is rarely read as a procedure, and that is exactly where it goes wrong. Article 20 places four measures side by side that differ sharply in practice, and those four are not legally equivalent. Recall and withdrawal are defined in Article 3(16) and (17), and the knowledge base carries those terms separately; the difference between them is the point in the chain. Bringing a system into conformity is the patch. Disabling is the odd one out: it is practically the heaviest switch, because it stops a customer who is running the system, and it is at the same time the only one of the four the Regulation nowhere defines. Anyone who copies that word into a contract or procedure without deciding for themselves what it means leaves the heaviest measure the vaguest. The second half is the notification, and in practice that is what fails most often. Paragraph 1 asks you to reach your distributors and, where applicable, your deployers, authorised representatives and importers, which is only possible if you hold a current list of who runs the system in which version and through which contact you reach them. That list is not a by-product of your CRM: resale, white labelling and integration mean you have customers you do not know.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 20(1)-(2)","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":"Paragraph 2 and Article 73 are often built as a single reporting channel, and that goes wrong in two ways. The trigger differs: Article 73 concerns a serious incident that has occurred, Article 20(2) a risk within the meaning of Article 79(1), that is, a risk to the health, safety or fundamental rights of persons. That is not a tidy split between past and future: a serious incident that has occurred usually also means the system presents a risk, so in practice both provisions often fire at the same time. Nor do the recipients differ entirely, because both routes run to market surveillance authorities. The difference sits in the detail: Article 73(1) points to the authorities of the Member States where the incident occurred, Article 20(2) to the authorities competent for the system concerned, and only Article 20(2) adds the notified body that issued a certificate under Article 44. Only Article 73, moreover, sets hard deadlines. So build one internal process with two exits, not two separate channels and not one channel that forgets the notified body.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 20(2), Article 73(1)-(2) and Article 79(1)","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":"Write out the four measures in paragraph 1 as four concrete scenarios with an owner, a decision maker and a lead time, and decide for yourself what disabling means in your system, because the Regulation does not define that term. Test at least once whether you can actually disable or recall a system without needing a fresh decision to do so. Also keep a record, per system version, of who runs it and through which contact you reach that party, and record which signal meets the \"reason to consider\" threshold in your organisation, so that the moment of becoming aware is demonstrable rather than something reconstructed after the fact.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 20(1)-(2)","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"}]},{"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"}]}],"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"}],"first_actions":[{"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."},{"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":"Set up the procedure for corrective actions and notification","summary":"Work out the four measures in paragraph 1 as scenarios with an owner and a lead time, keep a record per system version of who runs it and how you reach that party, and set out the route along which the investigation of causes, the notification to the market surveillance authorities and the message to the notified body run once paragraph 2 comes into play."}],"evidence":[{"label":"Conformity file","summary":"The assessment, EU declaration of conformity, CE marking and registration proof, per system version.","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":"Record of corrective actions","summary":"Per case: which signal came in and when, which system and which version it concerned, which measure was chosen and why, who decided on it, which parties were informed and when, and what the investigation of causes produced. This is the file that shows that \"immediately\" is a moment in your organisation rather than an estimate after the fact.","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":"Toys: manufacturer opts for internal control based on standards","situation":"A toy manufacturer whose product contains an AI system as a safety component applies harmonised standards and thereby opts for a conformity assessment procedure without third-party involvement.","outcome":"The Commission draft guidelines of 19 May 2026 address this case when determining whether AI as a safety component falls under the Annex I product legislation. The document is a consultation version: non-binding and not yet final.","lesson":"Opting for internal control based on harmonised standards without a third party changes your procedure but not the classification: the system remains high-risk and the accompanying obligations still apply.","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex I and product legislation","provenance":"official"},{"label":"Admission system at a higher education institution: who registers in the EU database","situation":"A higher education institution procures an AI system that organises student applications and enrolment and produces an admission recommendation for each candidate in its vocational programmes. The supplier says it handles the conformity assessment itself and affixes the CE marking. What is left unresolved is whether the institution still has a step of its own to take before the system goes into use in its teaching.","outcome":"Article 43(2) provides that for high-risk AI systems referred to in points 2 to 8 of Annex III, providers follow the conformity assessment procedure based on internal control set out in Annex VI, which does not provide for the involvement of a notified body. Article 47(1) requires the provider to draw up, for each high-risk AI system, a written machine-readable, physical or electronically signed EU declaration of conformity and to keep it at the disposal of the national competent authorities for ten years after the system has been placed on the market or put into service. Article 49(1) requires the provider or, where applicable, the authorised representative to register themselves and their system in the EU database referred to in Article 71 before an Annex III high-risk system is placed on the market or put into service, with the exception of the systems listed in point 2 of Annex III. Article 49(3) provides that deployers that are public authorities or Union institutions, bodies, offices or agencies, or persons acting on their behalf, register themselves, select the system and register its use in that same database before putting such a system into service or using it, again with the exception of the systems listed in point 2 of Annex III.","lesson":"We read Article 49 as two separate registrations: paragraph 1 covers the provider and its system, paragraph 3 covers your own use, and on that reading the first does not relieve you of the second. The hinge question for the institution is therefore not whether the supplier does its job, but whether it is a public authority within the meaning of paragraph 3. The Regulation does not define that term, and until that is settled it remains open whether the institution must itself appear in the EU database. In practice we would move the request for the EU declaration of conformity and the registration number into the procurement stage, so that the question does not turn into a blocker just before an application period opens.","source_locator":"Article 43(2), Article 47(1) and Article 49(1) and (3)","provenance":"editorial"},{"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":"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":"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/conformiteitsbeoordeling-ce","follow_up_questions":[{"question":"Do we need to register our AI system in the EU database?","url":"https://www.praxikon.com/en/antwoord/eu-databank-registratie"},{"question":"What technical documentation does the AI Act require (Article 11)?","url":"https://www.praxikon.com/en/antwoord/technische-documentatie"},{"question":"What does the Article 9 risk management system require from us?","url":"https://www.praxikon.com/en/antwoord/risicomanagement-hoog-risico"}],"disclaimer":"General interpretation, not legal advice. The official source remains authoritative.","methodology":"https://www.praxikon.com/en/methodologie"}