Article 16: Obligations of Providers of High-Risk AI Systems

Article 16 is a routing table — it lists every obligation a high-risk AI provider must meet and points to the article where each is detailed. The provider shall:

(a) Ensure compliance with the requirements in Section 2 (Articles 8–15): - Article 9 — Risk management system - Article 10 — Data and data governance - Article 11 + Annex IV — Technical documentation - Article 12 — Record-keeping / logging - Article 13 — Transparency and information to deployers - Article 14 — Human oversight - Article 15 — Accuracy, robustness, and cybersecurity

(b) Put in place a quality management system — Article 17

(c) Keep the technical documentation — Article 11

(d) Keep logs automatically generated by the system when under their control — Article 12

(e) Carry out the relevant conformity assessment before market placement — Article 43

(f) Comply with registration obligations — Article 49

(g) Take necessary corrective actions — Article 20

(h) Affix CE marking — Article 48

(i) Draw up the EU declaration of conformity — Article 47

(j) Establish and maintain a post-market monitoring system — Article 72

Always confirm the full lettered list on EUR-Lex Article 16.

In practice, Article 16 is the article compliance teams print and hang on the wall. It answers: *"What must I do before I can ship?"* Each bullet gives you a checklist item with a direct link to the detailed requirement article. Missing any single point blocks lawful market placement.

Use Article 16 as the backbone of your compliance programme: map each lettered obligation to an internal workstream owner, timeline, and evidence artefact.

• Article 6 — Determines whether Article 16 applies (high-risk classification).
• Articles 8–15 — The Section 2 requirements referenced by Article 16(a).
• Article 17 — QMS — referenced by Article 16(b).
• Article 25 — Re-qualification: deployers/distributors/importers who trigger re-qualification inherit the full Article 16 set.
• Article 26 — Deployer obligations (counterpart to Article 16 for the downstream actor).
• Article 43 — Conformity assessment — referenced by Article 16(e).
• Article 47 — EU declaration of conformity — referenced by Article 16(i).
• Article 48 — CE marking — referenced by Article 16(h).
• Article 49 — Registration — referenced by Article 16(f).
• Article 72 — Post-market monitoring — referenced by Article 16(j).
• Article 99 — Penalties for non-compliance.
• Article 113 — Application dates.

The recitals in the same consolidated AI Act on EUR-Lex contextualise provider accountability, proportionality for SMEs, and the lifecycle approach. Use the official preamble on EUR-Lex.