Technical documentation under the Machinery Directive: requirements, content and responsibilities.

Establishing and managing technical documentation for machinery is a central part of the Machinery Directive and a prerequisite for CE marking. The documentation demonstrates that a machine complies with the essential health and safety requirements and serves as evidence vis-à-vis authorities and users. 

Requirements for technical documentation 

For the documentation to be valid, it must meet the following requirements: 

Retention period: must be retained for at least 10 years from the date of manufacture of the machine. 

Language: must be written in an official EU language. 

Availability: must be produced on request for the competent national authorities. 

Traceability: the content must be traceable back through its origin, assignment of responsibilities, and modifications. 

What must technical documentation include?

Technical documentation must show how the machine complies with the essential requirements.

It must include:

• Description of the machine and its function

• Risk assessment

• Protective measures and residual risks

• Drawings and control systems

• Calculations and verification

• Standards applied

• Test results

• Instructions for use

• EU Declaration of Conformity

Where applicable, also:

• Documentation for partially completed machinery

• Documentation for integrated products

• Procedures for series production

It is this documentation that is reviewed during an inspection - not just the CE marking.

Responsibilities of the operator and employer

Even after manufacture, responsibility for documentation and safety may lie with operators and employers, particularly when machinery is modified. If the modification does not qualify as a substantial modification, the operator/employer is responsible for safety. This means that one must: 

• Ensure that the work equipment is safe.

• Comply with national occupational safety legislation. 

• Comply with the Operational Safety Ordinance (e.g., Betriebssicherheitsverordnung in Germany)

• Prepare documentation as evidence of change control. 

Would you like to simplify technical documentation work?

Many manufacturers struggle with:

• fragmented documentation

• manual processes

• lack of traceability

With Noex, you can:

• structure documentation in accordance with legal requirements

• link risk to requirement to action

• manage both directives and regulations

• save time and reduce risk

Book a demo: https://noex.se/book-a-demo