Overview

Understanding the Machinery Regulation and Directive

The Machinery Regulation (EU) 2023/1230 was introduced in June 2023. This new regulation replaces the Machinery Directive (Directive 2006/42/EC) and has entered into force in all EU member states, with mandatory compliance starting from January 20, 2027. By this date, all economic operators — referring to all parties involved in the supply chain and distribution of machinery within the EU — must demonstrate compliance to the new requirements.

Note: Products can still be placed on the market under the current Machinery Directive 2006/42/EC until January 19, 2027. Additionally, products placed on the market via self-declaration of conformity with the Machinery Directive before January 20, 2027, can still be made available for distribution and sale after this date.

The Machinery Regulation aims to address the evolving technological landscape, particularly the integration of advanced digital technologies such as artificial intelligence and the Internet of Things (IoT).

It applies to the following related products, including machinery that is partly complete:

  • Interchangeable equipment
  • Safety components
  • Lifting accessories
  • Chains, ropes, and webbing
  • Removable mechanical transmission devices

Assessing Machinery Under the New Regulation

In simple terms, equipment assessment under the Machinery Regulation is governed by three main “Types” of standards:

  • Type A Standards: Basic concepts, design principles, and general aspects applicable to all machinery.
  • Type B Standards: Generic safety standards.
    • B1: Specific safety aspects like safety distances and noise.
    • B2: Safeguards like two-hand controls and interlocking devices.
  • Type C Standards: Detailed safety requirements for particular machines or groups, such as hydraulic presses or packaging machines.
CE Marking: Demonstrating Compliance

Products fully compliant with the Machinery Regulation will carry the CE mark, indicating adherence to the required standards for the EU. Manufacturers of products with the CE marking must create a technical file containing information that demonstrates compliance with applicable requirements.

Affixing the CE mark is often a self-declaration process. However, many manufacturers engage third-party experts, like CSA Group, to assist in this journey, helping equip manufacturers with confidence in meeting the Machinery Regulation’s requirements.

How CSA Group Can Support Manufacturers Navigate the Machinery Regulation and Directive
Support Services
  • Training and Support: A range of flexible and personalized training and support solutions to assist in building awareness and knowledge of Machinery Regulation requirements, giving manufacturers the confidence to create a technical file.
  • Standards Identification: Provide support in determining which Type A, B, and C standards apply to your machinery.
  • Risk Assessment Review and Facilitation: Review of a completed risk assessment process to identify health and safety hazards in machinery, identifying gaps in the file, and providing findings of our reviews.
  • Documentation and “CE” Support: Guidance and support to help create a technical file, including support with key documents to include labels and Declaration of Conformity (DoC) requirements.
Evaluation Services
  • Compliance Assessment: Evaluation of machinery against key standards, such as EN ISO 12100 (for general principles of design, risk assessment, and risk reduction), along with relevant Type “B” and “C” standards.
  • Foreseeable Misuse: Identifying potential misuse scenarios and assessing risks based on severity and probability.
  • Risk Mitigation: Evaluate health and safety requirements, including risks to machine operators and bystanders (those who are not operating the equipment but will be in proximity), as well as providing guidance on risk-mitigation mechanisms to reduce risks as required.
Support for Related Regulations and Directives:
  • Electrical Safety: As part of the technical review, CSA Group can evaluate compliance with the electrical safety standard EN 60204-1, applicable to machinery with electrical components.
  • Functional Safety: CSA Group offers an extensive range of functional safety services, including assessments of harmonized functional safety standards relevant for the Machinery Regulation and Directive.
  • CE-Related Regulations and Directives: We can assist with a variety of testing services applicable to the EMC Directive (2014/30/EU), Radio Equipment Directive (2014/53/EU), Restriction of Hazardous Substances (RoHS), Waste from Electrical and Electronic Equipment (WEEE), and Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).

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