CE marking of machinery: the essential guide

CE marking on a machine is not a certificate issued by a third party. In the vast majority of cases it is a self-declaration by the manufacturer, made under their own responsibility, confirming that the essential safety requirements set out in EU legislation have been met. Understanding this distinction is the first step to not being misled into thinking "having the CE mark" is enough on its own.

What CE marking actually is

It is not a quality award: it is a declaration of conformity with minimum safety requirements, affixed by the manufacturer under their own responsibility. It applies to a wide range of products — machinery, personal protective equipment, electrical devices — but this guide focuses on machinery, the most common case for anyone running an industrial plant within the EU single market.

The regulatory framework: from the Machinery Directive to the new Regulation

For years the reference was the Machinery Directive 2006/42/EC. Since 2023, the new Machinery Regulation (EU) 2023/1230 has been in force and will gradually replace it, with full application from January 2027. The main changes concern explicit requirements for safety software and AI systems integrated into machinery, along with updated criteria for certain categories considered high-risk.

The technical file

This is the collection of documents that demonstrates, point by point, how the machine meets the essential safety requirements. A complete technical file typically contains:

• construction drawings and diagrams of the machine;
• the risk assessment carried out during design;
• the list of harmonised standards applied;
• instructions for use in a language understood by the end user;
• the CE declaration of conformity signed by the manufacturer.

It must be kept by the manufacturer for at least 10 years from the end of production of the machine.

Risk assessment: the heart of the process

This is the step that gives real substance to everything else. The typical procedure involves identifying the hazards associated with the machine, estimating and evaluating the risk for each of them, and adopting reduction measures — first through design, then through protection, and finally through information for the user. The cycle repeats until the residual risk is considered acceptable.

When a notified body is required

For most machinery, the manufacturer can self-certify conformity through an internal self-assessment. For machinery listed in Annex IV — considered high-risk, such as certain presses or woodworking machines with specific characteristics — involvement of a notified body is typically required, unless the manufacturer applies the relevant harmonised standards in full.

Used and modified machinery

Two cases that often raise questions: a used machine that was never CE marked may require a new conformity assessment if resold. And a substantial modification to an existing machine — one that changes its intended use or increases its risk — can trigger the obligation for a new CE marking, at the responsibility of whoever carries out the modification, not the original manufacturer.

What about Great Britain, post-Brexit?

The United Kingdom now operates its own UKCA (UK Conformity Assessed) marking system for the Great Britain market, running alongside CE marking. Whether and until when CE marking alone remains accepted for GB has been a moving target — the UK government has extended the relevant deadlines more than once. If you trade with Great Britain, treat this as something to verify against current official UK guidance at the time of shipment, not something to assume from an article, however recently updated.

Common mistakes

• Believing the mark on the plate is enough, without a real technical file behind it — which is what actually matters in an inspection or after an accident.
• Buying machinery from outside the EU without verifying the actual availability of the technical file and declaration of conformity.
• Not updating the risk assessment after significant changes to the plant or the production process the machine is part of.