Machinery Regulation Annex I: High-Risk Machine Categories, Part A vs Part B Rules [2027]
What is the difference between Part A and Part B of Annex I in Machinery Regulation 2023/1230? Annex I replaces Annex IV of the old directive. Part A lists machinery categories where third-party Notified Body assessment (EU Type-Examination or Full Quality Assurance) is strictly mandatory, even if the manufacturer applies harmonized European standards in full. Part B contains categories where self-assessment under Module A (Internal Production Control) remains permitted provided harmonized standards covering all relevant hazards are applied in full; if no harmonized standard exists or if it is only partially applied, Part B machines must also go through a Notified Body.
Detailed analysis of Annex I categories under Regulation (EU) 2023/1230: mandatory Notified Body intervention in Part A vs self-assessment under Part B.
Technical Specifications & Regulatory Comparison Matrix
| Annex I Category | Annex I Section | Conformity Route with Harmonized Norms | Conformity Route without Harmonized Norms |
|---|---|---|---|
| AI-Driven Safety Components & Logic | Part A (Point 1) | Mandatory Notified Body (Module B+C or H) | Mandatory Notified Body (Module B+C or H) |
| Autonomous Mobile Machinery with Self-Evolving Logic | Part A (Point 2) | Mandatory Notified Body (Module B+C or H) | Mandatory Notified Body (Module B+C or H) |
| Mechanical & Hydraulic Presses for Cold Working of Metals | Part B (Point 14) | Self-Assessment (Module A) allowed | Mandatory Notified Body (Module B+C or H) |
| Injection & Compression Moulding Machines for Plastics/Rubber | Part B (Point 15) | Self-Assessment (Module A) allowed | Mandatory Notified Body (Module B+C or H) |
| Vehicle Servicing Lifts | Part B (Point 18) | Self-Assessment (Module A) allowed | Mandatory Notified Body (Module B+C or H) |
| Devices for the Lifting of Persons (>3m) | Part B (Point 19) | Self-Assessment (Module A) allowed | Mandatory Notified Body (Module B+C or H) |
1. Why Part A Re-establishes Mandatory Third-Party Inspection
Under Directive 2006/42/EC, manufacturers could self-certify all Annex IV machines if they strictly followed harmonized Type-C standards. The European Commission recognized that emerging technologies—specifically self-evolving artificial intelligence and connected safety algorithms—carry emergent risks that standardized tests cannot anticipate. Part A removes the self-assessment privilege for these cutting-edge categories.