Conformity assessment, CE marking and registration
Articles 43, 47, 48 and 49.
Your mandated EU point of contact under Article 22 of the AI Act
Article 16 lists what a provider of a high-risk AI system must do before and after placing it on the EU market. For Annex III systems these obligations apply from 2 December 2027; for Annex I product-related systems from 2 August 2028.
| Obligation | Where in the AI Act |
|---|---|
| Meet the requirements for high-risk systems: risk management, data governance, technical documentation, record-keeping, transparency to deployers, human oversight, accuracy, robustness and cybersecurity | Articles 8-15 |
| Indicate the provider's name, registered trade name or trade mark and contact address on the system, packaging or documentation | Article 16(b) |
| Quality management system | Article 17 |
| Keep documentation for 10 years after placing on the market | Article 18 |
| Keep automatically generated logs under the provider's control | Article 19 |
| Conformity assessment before placing on the market | Article 43 |
| EU declaration of conformity and CE marking | Articles 47 and 48 |
| Registration in the EU database (Annex III systems) | Article 49 |
| Corrective actions and information duties | Article 20 |
| Post-market monitoring and serious incident reporting | Articles 72 and 73 |
| Accessibility requirements | Article 16(l) |
Before making a high-risk AI system available on the Union market, a provider established in a third country must appoint, by written mandate, an authorised representative established in the Union (Article 22). The representative verifies the declaration of conformity and technical documentation, keeps documents available to authorities for 10 years, and cooperates with competent authorities. See Article 22 explained.
Under the Digital Omnibus, Annex III high-risk systems placed on the market before 2 December 2027 are subject to the requirements only if their design changes significantly after that date; other units of the same type and model can continue to be placed on the market while the design stays unchanged (Article 111(2)). Systems intended for use by public authorities must comply by 2 August 2030.
SMEs, and since Regulation (EU) 2026/1744 also small mid-cap enterprises (fewer than 750 employees and turnover up to EUR 150 million or balance sheet up to EUR 129 million), can use simplified technical documentation and more proportionate quality management expectations.
For high-risk AI systems under Article 6(2) and Annex III from 2 December 2027, and for systems under Article 6(1) and Annex I from 2 August 2028, as amended by Regulation (EU) 2026/1744.
For 10 years after the high-risk AI system has been placed on the market or put into service (Article 18).
Yes. Providers established outside the EU must appoint an authorised representative established in the Union by written mandate before making a high-risk AI system available on the EU market (Article 22).
Articles 43, 47, 48 and 49.
Annex III categories.
Our authorised representative service.
Note: This guide provides general information about Regulation (EU) 2024/1689 (AI Act) as amended by Regulation (EU) 2026/1744 (Digital Omnibus on AI), not legal advice. Last reviewed 5 October 2026.