Machinery Regulation (EU) 2023/1230

What Does the New EU Machinery Regulation Entail?

The EU's new Machinery Regulation (EU) 2023/1230 replaces the Machinery Directive 2006/42/EC and will become binding law throughout the EU from January 20, 2027. It changes the landscape for how machines are designed, documented, and CE marked. The focus is shifted to digital security, AI-driven systems, and continuous risk management.

Background - Why a New Regulation?

The Machinery Directive has been the foundation of European machine safety since 1989, but the currently revised version 2006/42/EC was adopted in 2006 and became binding from December 2009. However, the industry has evolved - automation, remote control, and AI have necessitated new regulations. The new regulation is a legally binding framework (unlike a directive) and applies directly in all member states without national implementation.

It complements several other EU laws, including:

• Cyber Resilience Act (CRA)

• AI Act

• LVD, EMC, and RED Directives

The Major Changes (Overview for All Audiences)

Educational Overview - How the Machinery Regulation Works

1. Identify if Your Product Is Covered

   All products defined as machines, safety components, lifting accessories, chains, ropes, belts or interchangeable equipment are covered.

Tip: Many believe that small automated units (e.g., robotic cells or integrated modules) do not count - but they almost always do according to Article 3.

2. Classify Risk Level

The regulation categorizes machines into two categories:

• Annex I - Section A - High-Risk Machines: requires external assessment by a notified body.

• Annex I - Section B - Risk Machines: self-assessment is often sufficient, but external assessment may be needed in two situations.
  
  

  1. If you use a harmonized standard partly or not at all

  If you do not meet all relevant harmonized standards giving presumption of conformity, internal control is insufficient.
  
  

  In this case, you must use one of the following modules:

  EU-type examination (module B) and

  Module C (conformity with type) or

  Module E (quality assurance) or

  Module F (product verification)

  These involve an external body.
  
  

  2. If the machine includes safety components falling under Annex I A

  Example: AI-based safety functions.

  An external body may become mandatory even if the machine itself is listed in Section B.

  
  

3. Perform Risk Assessment and Design Protection

Use EN ISO 12100 as method support.

• Identify Hazards

• Assess Probability and Severity

• Take protective measures in order: built-in safety → protection → information

  
  

4. Establish Technical Documentation

According to Article 10.3 the manufacturer must store all documentation for at least 10 years.

Documentation can be entirely digital, and must include:

• Description of the machine/product and its intended use.

• Risk assessment, including:

The essential health and safety requirements (found in Noex).
Protective measures and residual risks.

• Drawings and diagrams (construction, manufacture, components, circuits).

• Explanations necessary to understand drawings and functions.

• Applied standards/GS, including parts used in partial application.

• Other technical specifications when standards are not or only partially followed.

• Calculations, tests, trials, and controls verifying conformity.

• Manufacturing methods ensuring compliance with design.

• Instructions for use and user information according to Annex III point 1.7.4.

• EU declaration of incorporation + assembly instructions (for partially completed machinery).

• EU declarations of conformity for embedded products covered by other EU legislation.

• Internal procedures for serial production ensuring continued conformity.

• Source code or programming logic for safety-related software (upon justified request).

• For sensor-controlled/remote-controlled/autonomous products:

• System characteristics, capabilities, limitations, as well as data, test, and validation processes.

• Test and inspection results showing the product can be assembled and put into service safely.

4. CE Mark and Declare Conformity

Once requirements are met, affix the CE mark visibly on the product and establish EU declaration of conformity.

Tip: Specify the correct legal act - write "(EU) 2023/1230" instead of the old "2006/42/EC".

Technical Overview - The Machinery Regulation for Industry Experts

Essential Health and Safety Requirements (EHSR)

Annex III lists fundamental requirements for safe construction. Examples of novelties:

• EHSR 1.1.9: Protection against tampering, a completely new requirement.

• EHSR 1.2.1: Protection against external influence, tracking log for safety software and interventions, and specific requirements for control systems with self-developing behavior.

• EHSR 1.2.6: Inclusion of communication networks.

Integration of AI Systems

If a machine uses AI for control, decision-making, or adaptation, it must:

1. Be predictable - no "black-box logic".

2. Include risk assessment of how algorithms affect safety functions.

3. Always be correctable to maintain its inherent safety.

Requirements for Digital Documentation

The regulation allows digital archiving but imposes requirements on:

• Accessibility: a notified body or authority must have direct access.

• Version Management: all updates must be timestamped.

• Authenticity: data must be protected against alteration (e.g., through digital signing or version control on the Noex platform)

Roles and Responsibilities

Important: When you build a production line of multiple machines, you become a new manufacturer according to Article 10.

Consequences if You Do Not Follow the Machinery Regulation

• CE marking may be invalidated

• Prohibition of sales within the EU

• Recalls and sanctions (up to 10% of annual turnover)

• Civil liability in case of accidents

Example: A company may be prohibited from selling machines with embedded AI control if they cannot prove that the AI algorithm has been validated according to Annex III - even if the product is otherwise CE-marked.

Common Mistakes to Avoid

• Using old references to machinery directive in documentation

• Confusing "high-risk machine" with "dangerous machine" - the classification is legal

• Underestimating cybersecurity requirements

• Failing to update manuals when software updates occur

FAQ Machinery Regulation (EU) 2023/1230

1. When does the Machinery Regulation become applicable?
   Answer: It becomes applicable on January 20, 2027, but companies should adapt by 2026 at the latest.

   
   

2. Do I need to redo CE marking for existing machines?
   Answer: No, not retroactively - but upon modification, integration, or new version, it must meet the regulation's requirements.

   
   

3. What if I lack digital documentation?
   Answer: You risk sales halts and lack of traceability during oversight. The regulation requires secure and accessible storage for at least 10 years.