Annex I – EU Harmonisation Legislation
Overview
Annex I lists the EU harmonisation legislative acts under which AI systems may qualify as safety components of the regulated product (Art. 6(1)).
Section A – Relevant Legislative Acts (Selection)
| Legislative Act | Typical Products | BAUER GROUP Relevance |
|---|---|---|
| Machinery Regulation (EU) 2023/1230 | Industrial machinery, robots | ⚠️ Embedded AI in robotics |
| Medical Devices Regulation (EU) 2017/745 | Medical devices with AI | ❌ Not in portfolio |
| Lifts Directive 2014/33/EU | Lifts with AI control | ❌ Not in portfolio |
| Radio Equipment Directive 2014/53/EU | IoT devices with AI | ⚠️ Check IoT products |
| Low Voltage Directive 2014/35/EU | Electrical equipment | ❌ Not relevant |
| Toys Directive 2009/48/EC | AI toys | ❌ Not in portfolio |
| Cableway Regulation (EU) 2016/424 | Cableways | ❌ Not relevant |
Section B – Additional Legislative Acts
Section B covers additional legislative acts (civil aviation, vehicle safety, etc.) for which the high-risk classification takes effect only from 2 August 2027.
BAUER GROUP Assessment
For the BAUER GROUP, the primarily relevant items from Annex I are:
- Machinery Regulation — only if BAUER GROUP markets autonomous robotics systems with AI control under its own name
- Radio Equipment Directive — only if IoT devices (ESP32 etc.) contain a safety-relevant AI decision-making component
Practical Rule
Our IoT/embedded products typically use deterministic firmware. AI components (e.g. edge ML for anomaly detection) are not safety-relevant within the meaning of Annex I. A case-by-case assessment is required for new products.