What the EU Machinery Regulation is really about

Understanding the Machinery Regulation - FAQ

• Who is affected?

  The EU Machinery Regulation does not only apply to traditional machine manufacturers. It is particularly relevant for:

  • Manufacturers of machines, safety components and partly completed machinery
  • Plant manufacturers and system integrators
  • Companies carrying out retrofit, modification or modernisation projects
  • Manufacturers of software-intensive or connected industrial products
  • Professionals responsible for quality, safety, security and compliance
  • Testing organisations as well as technical documentation and certification teams

  Companies that place products on the market under their own name or carry out substantial modifications should also assess their regulatory role at an early stage.

• Who is responsible for what?

  The EU Machinery Regulation defines clear responsibilities for all parties involved:

  • Manufacturers bear primary responsibility for safety and compliance
  • Integrators must ensure that overall systems function safely
  • Placing-on-the-market entities assume responsibility when products are supplied under their own name
  • Operators must assess modifications and retrofits

  It is important to note that responsibilities can shift quickly — particularly in the context of software updates or system integration.

• What has changed compared to the Machinery Directive?

  With the replacement of the Machinery Directive by the Machinery Regulation, several important topics are being addressed:

  • Ensuring cyber security – mandatory protection of control systems and safety-related software against cyber attacks, manipulation and unauthorised external access.
  • Assurance of AI systems performing safety functions – ensuring that AI-based safety functions meet the applicable safety and compliance requirements.
  • Responsibilities of distributors and importers – distributors and importers are required to verify machinery compliance and report risks and non-compliance to manufacturers and market surveillance authorities.
  • Digital operating instructions – operating instructions may be provided in digital form.
  • Substantial modifications – anyone making a substantial modification to a machine may be considered the manufacturer and must then fulfil the corresponding regulatory obligations.

• What requirements apply?

  Key requirements of the EU Machinery Regulation include:

  • Conducting a systematic risk assessment
  • Implementing appropriate protective measures
  • Demonstrating compliance with essential health and safety requirements
  • Preparing complete technical documentation
  • Providing operating instructions (also possible in digital form)
  • Carrying out conformity assessment and CE marking

  A key new aspect is the stronger focus on digital and software-based functions.

• Why is software a critical factor?

  Modern machines increasingly incorporate software-based and connected components.

  This gives rise to new questions:

  • How are software faults addressed in the risk assessment?
  • What impact do updates have on conformity?
  • How are safety-related control systems validated?
  • What role does cybersecurity play in functional safety?

  As a result, safety is no longer purely mechanical — it becomes systemic.

• What role does risk assessment play?

  Risk assessment remains the core of the EU Machinery Regulation — but it is becoming more complex.

  It now needs to take into account:

  • Mechanical, electrical and functional risks
  • Software and control logic
  • Connectivity and external interfaces
  • Misuse and tampering
  • Interactions within the overall system

  An isolated assessment of individual components is no longer sufficient.

• Why is implementation complex?

  The main challenge does not lie in individual requirements, but in how they interact:

  • Mechanics, electronics and software are closely interlinked
  • Safety and security aspects increasingly overlap
  • Multiple EU regulations must be complied with simultaneously
  • Evidence must be consistent and auditable

  Without a structured approach, gaps in development and documentation can quickly arise.

• How does the Machinery Regulation relate to the CRA and the AI Act?

  DThe EU Machinery Regulation does not stand alone, but forms part of a broader regulatory framework.

  Depending on the product, particularly relevant are:

  • Cybersecurity requirements for connected products (e.g. the Cyber Resilience Act)
  • Requirements for AI-based systems (e.g. the EU AI Act)
  • Additional product-specific directives and regulations

  For companies, it is crucial to consider these requirements in an integrated manner.