Machinery Directive 2006/42/EC: navigating grey areas

Defining Stand-Alone Machinery, Partly Completed Machinery, and Assemblies under the Machinery Directive 2006/42/EC

The Machinery Directive 2006/42/EC provides a comprehensive framework for the safety and compliance of machinery within the European Economic Area (EEA). For manufacturers engaged in the CE conformity assessment of industrial machinery, distinguishing between stand-alone machinery, partly completed machinery, and assemblies of machinery presents significant challenges. This article delves into the theoretical foundations of these categories and how to define them for CE marking, drawing on the expert approach of Certification Company.

Stand-Alone Machinery

Stand-alone machinery is an individual machine that operates independently and performs specific functions without dependency on other machines. These machines are characterized by their autonomous functionality, as they are designed to perform their intended functions without requiring integration with other machinery. A stand-alone machine is considered a complete product, meeting all applicable Essential Health and Safety Requirements (EHSRs) of the Machinery Directive.

The conformity assessment process for stand-alone machinery involves ensuring that the machine meets all relevant EHSRs outlined in Annex I of the Machinery Directive. This requires a thorough risk assessment to identify and mitigate potential hazards inherent to its operation. Additionally, manufacturers must prepare comprehensive technical documentation, including design specifications, risk assessments, and safety measures. Upon confirming compliance, a Declaration of Conformity (DoC) is issued, and the CE mark is affixed to the machine, indicating it meets all regulatory requirements.

Partly Completed Machinery

Partly completed machinery refers to machinery that is almost finished but cannot perform a specific function on its own. It is intended to be incorporated into other machinery or assemblies to complete its functionality. This type of machinery lacks the necessary components or systems to operate independently and is designed for integration.

For partly completed machinery, the conformity assessment process includes compliance with EHSRs applicable to the stage of completion, documented in a risk assessment. Manufacturers must prepare technical documentation specific to the completed part, detailing the design, intended use, and safety measures. Instead of a DoC, a Declaration of Incorporation (DoI) is issued, indicating the machinery’s compliance with relevant EHSRs and stating that it should not be put into service until the final machinery is compliant. Furthermore, integration documentation must be provided to ensure safe incorporation into the final machinery.

Assembly of Machinery

An assembly of machinery consists of multiple machines or partly completed machinery that are integrated to function as a single entity. These assemblies are characterized by their functional integration, where the machines are interconnected and interact to perform a unified function. Typically, assemblies are governed by a shared control system to ensure coordinated operation, and they have a composite risk profile that requires a comprehensive risk assessment of the entire assembly to ensure that integration does not introduce new risks.

The conformity assessment for assemblies of machinery involves ensuring that each individual machine meets its EHSRs and that the assembly as a whole complies with all relevant EHSRs. This requires compiling a unified technical file that encompasses the design, risk assessments, and safety measures of the entire assembly. A collective Declaration of Conformity (DoC) must be issued for the assembly, confirming compliance with the Machinery Directive. Finally, the CE mark is affixed to the assembly, indicating overall compliance.

Approach to Defining Machinery

Understanding and defining machinery types require a conceptual framework that considers functionality, integration, and compliance requirements. This framework helps delineate the boundaries between stand-alone machinery, partly completed machinery, and assemblies of machinery.

1. Functional Autonomy

Determine whether the machinery can operate independently or requires integration with other machinery. Stand-alone machinery operates independently, whereas partly completed machinery and assemblies require integration.

2. Completeness of Function

Assess whether the machinery performs a specific function entirely on its own or if it is a component intended for integration. Stand-alone machinery performs complete functions independently, while partly completed machinery and assemblies do not.

3. Integration and Control

Evaluate the extent of integration and the presence of a common control system. It is essential particularly for assemblies of machinery. Assemblies typically involve a shared control system to ensure coordinated operation.

4. Risk Assessment

Conduct a detailed risk assessment for the machinery in its intended operational context, whether as a stand-alone unit, partly completed component, or part of an assembly. This assessment identifies and mitigates potential hazards associated with the machinery’s operation.

5. Regulatory Compliance

Ensure that the machinery meets the appropriate EHSRs and prepare the necessary documentation, whether a DoC or DoI, and technical files. It is a fundamental aspect of defining machinery types for CE marking.