Does high-risk AI need a conformity assessment and CE marking?

Yes. Before a high-risk AI system is placed on the EU market, its provider must carry out a conformity assessment (Article 43), draw up an EU declaration of conformity (Article 47) and affix the CE marking (Article 48). For most Annex III systems the provider can do this through internal control. Biometric systems, and AI inside products that already need a notified body, may need third-party assessment.

How it works

1. Confirm the system is high-risk and which assessment route applies.
2. Meet the requirements in Articles 8 to 15, and run a quality management system (Article 17), for which EN 18286 gives a presumption of conformity.
3. Complete the technical documentation and the declaration of conformity.
4. Register the system in the EU database where required (Article 49), then affix the CE marking.