Conformity Assessment, Standards, CE Marking, and Post-Market Duties

How a high-risk AI system actually gets to market: harmonized standards and presumptions of conformity, the Article 43 assessment routes, notified bodies and certificates, Annex IV documentation, the CE mark and EU database — and the post-market monitoring and serious-incident clocks that never stop running.

Content current as of 2026-09.

Lessons

1. Essential requirements, standards, and presumptions
2. Article 43: choosing your conformity route
3. Notified bodies, certificates, and the emergency valve
4. Annex IV, the declaration, the mark, and the database
5. Post-market monitoring, serious incidents, and audit readiness