Run conformity assessment and affix CE marking for a high-risk AI system under AI Act Articles 43, 47 and 48

Documented steps

1. For Annex III point 1 (biometrics) systems, choose the route under Article 43(1): internal control under Annex VI where harmonised standards under Article 40 or common specifications under Article 41 have been fully applied to all relevant requirements; otherwise the notified body route under Annex VII. Text: https://ai-act-service-desk.ec.europa.eu/en/ai-act/article-43
2. For Annex III points 2 to 8, apply internal control under Annex VI. Article 43(2) does not require notified body involvement for these, though Article 43(6) allows the Commission to change this by delegated act.
3. For Annex I products, follow the conformity assessment procedure in the relevant sectoral harmonisation legislation, with the Chapter III Section 2 AI requirements incorporated as set out in Article 43(3).
4. Note the special case in the final subparagraph of Article 43(1): where an Annex VII assessment concerns a system to be put into service by law enforcement, immigration or asylum authorities, or by Union institutions, bodies, offices or agencies, the relevant market surveillance authority acts as the notified body. You cannot select a private notified body.
5. Draw up a written EU declaration of conformity for each system containing the Annex V contents, in machine-readable, physical or electronically signed form, translated into a language the relevant national competent authorities can readily understand. Text: https://ai-act-service-desk.ec.europa.eu/en/ai-act/article-47
6. Where other Union harmonisation legislation also requires a declaration of conformity, issue a single declaration covering all applicable acts, per Article 47(3).
7. Keep the EU declaration of conformity at the disposal of the national competent authorities for 10 years after the system is placed on the market or put into service, and keep it updated.
8. Affix the CE marking per Article 48 and the general principles of Article 30 of Regulation (EC) No 765/2008: visibly, legibly and indelibly on the system, or on its packaging or accompanying documentation where that is not possible. For digitally provided systems use a digital CE marking accessible through the interface or an easily accessible machine-readable code. Text: https://ai-act-service-desk.ec.europa.eu/en/ai-act/article-48
9. Where a notified body was involved, follow the CE marking with that body's identification number, affixed by the body itself or under its instructions, and reproduce that number in promotional material referring to CE conformity.
10. Repeat the conformity assessment on any substantial modification under Article 43(4), excluding pre-determined changes disclosed in the technical documentation for systems that continue to learn after being placed on the market.
11. Check the AI Omnibus transitional provision allowing notified bodies already designated under sectoral harmonisation legislation to assess high-risk AI systems for a limited transitional period from 27 July 2026, and verify a body's authorisation basis and expiry before contracting it: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ%3AL_202601744
12. Diary the applicable date. The AI Omnibus amending regulation entered into force 27 July 2026 (OJ reference OJ:L_202601744, full text https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ%3AL_202601744). Per the Commission's official FAQ (https://digital-strategy.ec.europa.eu/en/faqs/navigating-ai-act), it postponed the high-risk rules of Chapter III to 2 December 2027 for Annex III systems and 2 August 2028 for AI embedded in regulated products (Annex I). Confirm the section-level scope of the postponement against the amended Article 113 text in the OJ before setting any internal deadline.