Industria

Machinery Regulation Annex I: High-Risk Machine Categories, Part A vs Part B Rules [2027]

Dr. Arthur Campbell (Industrial Compliance)
18 de septiembre de 2026
10 min min read
Machinery Regulation Annex I: High-Risk Machine Categories, Part A vs Part B Rules [2027]
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Detailed analysis of Annex I categories under Regulation (EU) 2023/1230: mandatory Notified Body intervention in Part A vs self-assessment under Part B.

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CONFORMITY ROUTES · HIGH-RISK MACHINERY

Machinery Regulation Annex I: High-Risk Machine Categories, Part A vs Part B Rules [2027]

DIRECT REGULATORY ANSWER (60 SECONDS):

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 CategoryAnnex I SectionConformity Route with Harmonized NormsConformity 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.

2. Criteria for Delegated Acts Expanding Annex I

Article 6 empowers the European Commission to amend Annex I by delegated acts based on market surveillance data, accident statistics, and technological progress. If a specific class of machinery demonstrates recurrent severe injuries, it can be reclassified from Part B to Part A, requiring third-party testing.

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Frequently Asked Questions (FAQ)

What notified bodies can certify Part A machinery?

Only conformity assessment bodies formally notified by EU member states specifically under Regulation (EU) 2023/1230 and listed on the European NANDO database.

Does a standard PLC qualify as an Annex I safety component?

No. Only safety components with fully autonomous self-learning or machine learning safety logic fall under Part A. Conventional safety PLCs (SIL 3 / PL e) certified under EN ISO 13849-1 remain under standard conformity rules unless combined with self-evolving algorithms.

📥 Lead Magnet: Annex I Self-Assessment vs Notified Body Decision Matrix

Determine whether your machine or safety component falls under Annex I Part A or Part B with our interactive decision tree for design engineers.

Download Compliance Template →

Editorial note: Last updated September 2026. Reviewed by the Igera Industrial Compliance Committee.

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