Annex I

Union Harmonisation Legislation

Plain-Language Summary

Lists EU product safety laws (Machinery, Medical Devices, Vehicles, etc.) whose products trigger high-risk classification for AI safety components under Article 6(1).

Keywords

machinerymedical devicesvehiclesaviationharmonisationconformity assessmenthigh-risk

Legal Text

Annex I — Union Harmonisation Legislation referred to in Article 6(1)

Section A — List of Union harmonisation legislation based on the New Legislative Framework:
1. Directive 2006/42/EC (Machinery)
2. Directive 2009/48/EC (Toy safety)
3. Directive 2013/53/EU (Recreational craft)
4. Directive 2014/33/EU (Lifts)
5. Directive 2014/90/EU (Marine equipment)
6. Directive 2016/424/EU (Cableways)
7. Directive 2014/35/EU (Low voltage electrical equipment)
8. Regulation (EU) 2016/424 (Cableways)
9. Regulation (EU) 2017/745 (Medical devices)
10. Regulation (EU) 2017/746 (In vitro diagnostic medical devices)
11. Regulation (EU) 2018/858 (Motor vehicles)
12. Regulation (EU) 2018/1139 (Aviation)
13. Regulation (EU) 2019/2144 (Vehicle type-approval)

Section B — List of Union harmonisation legislation based on sectoral approach:
14. Regulation (EU) No 300/2008 (Civil aviation security)
15. Regulation (EU) No 167/2013 (Agricultural vehicles)
16. Regulation (EU) No 168/2013 (Two/three-wheel vehicles)

Annex II →