When it comes to industrial equipment, the term “machine” is often used generically, sometimes including items that are, technically speaking, “partly completed machinery.” But what exactly distinguishes one from the other?

What Is a “Machine” According to Directive 2006/42/EC?

Directive 2006/42/EC defines a “machine” as:

• “An assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, joined together for a specific application.”

• “An assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion.”

• “An assembly referred to in the first and second indents, ready to be installed and capable of functioning only once mounted on a means of transport or installed in a building or a structure.”

• “Assemblies of machines referred to in the previous indents, or of partly completed machinery as defined in point (g), which are arranged and controlled so that they function as a whole.”

• “An assembly of linked parts or components, at least one of which moves and which are joined together for lifting loads, with only directly applied human effort as the power source.”

In summary, a “machine” is a set of components, at least one of which is movable, capable of performing a specific function autonomously (e.g. lifting loads or moving materials), without the direct use of human or animal force.

What Is “Partly Completed Machinery”?

According to Directive 2006/42/EC, “partly completed machinery” refers to:

“Assemblies which are almost machinery but which cannot in themselves perform a specific application.”

A typical example would be a drive system.

Partly completed machinery is designed solely to be incorporated into or assembled with other machines or equipment to form a system that complies with the directive.

In short, partly completed machinery cannot operate on its own—it needs to be integrated into a larger assembly to fulfill a useful function. Examples include an electric motor or an anthropomorphic robot, which only serve a clear purpose once built into a complete machine.

Why Does the Distinction Matter?

While both machines and partly completed machinery fall under Directive 2006/42/EC, the manufacturer’s obligations differ:

Risk assessment is mandatory for both and is used to identify hazards and necessary safety measures.

The certification process, however, varies:

For Machines:

Full CE marking procedure is required, ending with the application of the CE label.

For Partly Completed Machinery:

While Essential Health and Safety Requirements (EHSRs) must still be met, CE marking is not applied. Instead, specific technical documentation is required.

A Manufacturer of Partly Completed Machinery Must Provide Three Key Documents:

1️⃣ Relevant Technical Documentation

Similar to the technical file required for machines, this must:

Cover design, manufacturing, and operation;

Demonstrate compliance with applicable EHSRs;

Be drafted in one or more official EU languages;

Be available for at least 10 years from the date of manufacture (or of the last unit produced);

Not necessarily be kept within the EU, but must be made available upon request by authorities;

Include test reports, verifications, and analyses proving the safety of design and construction.

Legal reference: Annex VII of Directive 2006/42/EC.

Note: Failure to provide this documentation may raise doubts about the conformity of the partly completed machinery.

2️⃣ Assembly Instructions

Unlike machines, partly completed machinery must include an assembly manual that:

Describes how to correctly incorporate the item into the final machine;

Includes all safety-related warnings;

Is written in an official EU language accepted by the final machine’s manufacturer.

Legal reference: Annex VI of Directive 2006/42/EC.

3️⃣ Declaration of Incorporation

This document is the counterpart to the machine’s EC Declaration of Conformity and must:

Describe and identify the partly completed machinery;

Be issued in the official language of the EU country where it will be marketed;

List the EHSRs that are applied and fulfilled;

Declare that the partly completed machinery must not be put into service until it has been incorporated into a fully compliant machine;

Be retained in its original form for at least 10 years.

Legal reference: Annex II of Directive 2006/42/EC.

Note: The manufacturer (or their authorized representative) must provide this documentation upon request from competent authorities.

Conclusion

Although partly completed machinery cannot function on its own, Directive 2006/42/EC outlines a specific certification process to ensure compliance with relevant Essential Health and Safety Requirements.

Both the Declaration of Incorporation and the Assembly Instructions must accompany the partly completed machinery until it is fully integrated, and must be included in the technical file of the complete machine.