Annex II (AI Regulation)
EU sector legislation for high-risk AI integrated in products
Practitioner's note: This article is practice-oriented compliance documentation, not legal advice. We are a compliance specialist, not a law firm. For legally binding information please consult a licensed lawyer.
TL;DR
Annex II of the EU AI Act lists EU sector legislation under which an AI system is integrated as a safety component of a regulated product. Such AI is classified as high-risk (Article 6(1)(a)).
What is Annex II (AI Regulation)?
12 Annex II legal acts (excerpt):
- Machinery Regulation 2023/1230
- Medical Devices Regulation 2017/745
- In Vitro Diagnostic Medical Devices Regulation 2017/746
- Toy Safety Directive 2009/48
- Radio Equipment Directive 2014/53
- Pressure Equipment Directive 2014/68
- Lifts Directive 2014/33
- Marine Equipment Directive 2014/90
- Rail Interoperability Directive 2016/797
- Motor Vehicle Type-Approval Regulation 2018/858
- Aviation Safety Regulation 2018/1139
- EU Personal Protective Equipment Regulation 2016/425
Practical example
A manufacturer of an AI-controlled industrial machine falls under the Machinery Regulation 2023/1230 and the EU AI Act. A dual conformity assessment is required (machinery law plus AI Regulation Article 43).
Frequently asked questions
Double regulation?
Yes. Article 8(2) of the EU AI Act addresses avoidance of duplication — a joint conformity assessment is possible.
Which notified body?
A notified body that is notified for both legal acts (machinery law and the AI Regulation).
Transition periods?
These vary by sector. Machinery Regulation: 14 January 2027. AI Regulation high-risk Annex I: 2 August 2027 legally binding (Digital Omnibus proposal of 19 November 2025: postponement to 2 August 2028 — trilogue ongoing, not yet adopted).