Machinery Regulation Guide

Regulation (EU) 2023/1230 is the EU's new machinery safety law. Adopted by the European Parliament and the Council on the 14th of June 2023, it replaces the Machinery Directive 2006/42/EC as of the 20th of January 2027.

It’s also one of several directives that are covered by the CE marking regulations. That means demonstrating compliance with the Regulation is a mandatory part of the CE marking process for most products, equipment, and machinery sold within the European Economic Area (EEA).

This guide explains what the Machinery Regulation covers, who it applies to, what's changed from the old Directive, what conformity assessment and documentation are required, and how it fits into the wider CE marking framework.

Read the full Regulation (EU) 2023/1230 here.

What is the Machinery Regulation, and which equipment does it apply to?

In short, the Regulation sets the health and safety bar that machinery, related products and partly completed machinery must clear before they can be sold or used anywhere in the EU.

The goal is straightforward: keep people safe, especially the consumers and professional workers who use this equipment. And, where it's relevant, protect animals, property and the environment.

So what counts as "machinery"? At its core, it's any assembly of linked, moving parts, joined together for a specific job, and powered by something other than a person or animal pushing, pulling or lifting it directly. The Regulation stretches that core idea to also cover:

• Kits that are complete except for the on-site connections needed to hook them up to power or motion
• Equipment that only works once it's mounted on a vehicle, or built into a building or structure
• Several machines wired together and controlled as a single system, working toward the same end
• Manually-powered lifting gear (assemblies where a person supplies all the lifting force themselves)
• Machines that are finished in every respect except for the final software upload needed to run them

Alongside machinery itself, the Regulation covers the following categories of related products:

• Interchangeable equipment
• Safety components
• Lifting accessories
• Chains, ropes and webbing
• Removable mechanical transmission devices
• Partly completed machinery

Which equipment doesn’t the Regulation apply to?

Not everything falls in scope. The Regulation specifically excludes:

• Safety components supplied as identical spare parts by the original manufacturer
• Equipment for fairgrounds and amusement parks
• Machinery for nuclear installations, where compliance could undermine nuclear safety
• Weapons, including firearms
• Means of transport by air, water or rail, except machinery mounted on them
• Motor vehicles and trailers, two/three-wheel vehicles, quadricycles, and agricultural or forestry tractors already covered by their own EU type-approval Regulations, except machinery mounted on them
• Motor vehicles built exclusively for competition
• Seagoing vessels, mobile offshore units, and machinery installed on board them
• Machinery specially designed for military or police purposes
• Machinery for temporary use in research laboratories
• Mine winding gear
• Machinery intended to move performers during artistic performances
• Certain electrical and electronic products already covered by the Low Voltage Directive (2014/35/EU) or the Radio Equipment Directive (2014/53/EU), for example household appliances, audio/video equipment, IT equipment, and low-voltage switchgear and control gear

What changed from the Machinery Directive 2006/42/EC to the Machinery Regulation (EU) 2023/1230?

The Machinery Regulation came into force on 19 July 2023, but doesn't become fully applicable until 20 January 2027.

That's a transition period of roughly 42 months, giving manufacturers, notified bodies and national authorities time to prepare before the old Directive is repealed and the new Regulation takes over.

Here’s what changes:

It becomes a Regulation, not a Directive

The old Directive required transposition into the national law of each Member State. The Machinery Regulation applies directly and identically across the whole EU from the moment it takes effect, with no national transposition step in between.

New rules for machine learning and self-evolving machinery

Annex I now lists two entirely new categories that require the strictest level of conformity assessment:

1. Safety components with fully or partially self-evolving behaviour using machine learning
2. Machinery with embedded systems of the same kind that aren't independently placed on the market

The Regulation's general risk-assessment principles also now require manufacturers to consider hazards that could emerge over a machine's lifetime as a foreseeable result of this self-evolving behaviour.

New cybersecurity requirements

A new "protection against corruption" requirement means machinery must be designed so that connecting another device doesn't create a hazardous situation.

Hardware and software critical to compliance must be protected against accidental or intentional corruption, and the machinery must be able to identify its own safety-critical software and log evidence of legitimate or illegitimate intervention.

New control system requirements for autonomous machinery

Control systems for machinery with self-evolving or autonomous behaviour must not let it act beyond its defined task and movement space, must record data on safety-related decisions (retained for at least a year), and must always allow the machine to be corrected to maintain its inherent safety.

Human-machine interaction is now built into the ergonomics requirements

Where machinery is designed to operate with varying levels of autonomy, its human-machine interface must be adapted to the operators using it. And, where relevant, the machine should be able to respond to people appropriately and communicate its planned actions in a way they can understand.

Documentation can now be digital by default

Instructions for use, assembly instructions, and EU declarations of conformity or incorporation can all be provided digitally as standard, rather than defaulting to paper.

Manufacturers must mark how to access them, allow them to be printed, downloaded and saved, and keep them available online for at least 10 years after the product is placed on the market.

Traceability for safety software

Manufacturers must now keep a tracing log of any safety software versions uploaded after the machinery has been placed on the market or put into service, retained for five years, so conformity can be demonstrated on request.

"Substantial modification" is now formally defined

The Regulation sets out, for the first time, exactly what counts as a substantial modification and the consequences of making one.

Where a physical or digital change creates a new hazard or increases an existing risk in a way that needs extra guards, protective devices, or additional stability or strength measures, whoever carries it out is treated as the manufacturer for that machinery, and takes on the full set of manufacturer obligations, including conformity assessment and the EU Declaration of Conformity.

Importers and distributors now have their own formal obligations

In line with the EU's New Legislative Framework approach to product legislation, the Regulation sets out explicit duties for importers and distributors, rather than treating machinery compliance as a manufacturer-only concern.

Who's responsible for compliance?

The Machinery Regulation places obligations on:

• Manufacturers: Including those making machinery or related products for their own use
• Authorised representatives: Appointed in writing by the manufacturer to act on their behalf
• Importers: Who place products from outside the EU onto the Union market
• Distributors: Anyone else in the supply chain who makes a product available on the market

Anyone who carries out a substantial modification (a physical or digital change not foreseen by the manufacturer that creates a new hazard or increases an existing risk, requiring extra guards, protective devices, or additional stability or strength measures) is also treated as a manufacturer for that machinery. The exception is a non-professional user modifying their own machinery for their own use, who is not considered a manufacturer under the Regulation.

Key responsibilities for manufacturers include:

• Carrying out a risk assessment and designing the product to meet essential health and safety requirements
• Applying the appropriate conformity assessment procedure and drawing up the EU Declaration of Conformity
• Affixing the CE marking
• Compiling technical documentation
• Providing instructions for use in a language that users can easily understand
• Where instructions are provided digitally, marking how to access them, allowing them to be printed, downloaded and saved, and keeping them accessible online for the product's expected lifetime and at least 10 years after it's placed on the market
• Carrying out sample testing where appropriate, and keeping a register of complaints, non-conforming products and recalls
• For partly completed machinery: drawing up the EU Declaration of Incorporation and providing assembly instructions

Will it also apply in the UK and Northern Ireland?

Northern Ireland

Under the Windsor Framework, certain EU product rules continue to apply directly in Northern Ireland. The Machinery Regulation is one of these rules, and will apply directly in Northern Ireland from 20 January 2027.

Great Britain

Machinery in Great Britain is currently governed by the UK's own Supply of Machinery (Safety) Regulations 2008. However, the UK Government has confirmed it will continue to recognise CE marking in Great Britain, and that machinery CE-marked to the new Regulation can still be placed on the GB market without separate UKCA certification.

How do you carry out conformity assessment against the Machinery Regulation?

Annex I splits machinery and related products into two tiers, and the conformity assessment route depends on which one a product falls into.

Annex I, Part A, the highest-risk categories, currently covers:

• Removable mechanical transmission devices, including their guards
• Guards for removable mechanical transmission devices
• Vehicle servicing lifts
• Portable cartridge-operated fixing and other impact machinery
• Safety components with fully or partially self-evolving behaviour using machine learning
• Machinery with embedded systems of the same kind that haven't been placed independently on the market

For Part A categories, the manufacturer must use one of three routes, all of which involve a notified body:

• EU type-examination, followed by conformity to type based on internal production control
• Conformity based on full quality assurance
• Conformity based on unit verification (typically the route used for complex, customer-specific machines, where a notified body tests and certifies an individual machine rather than a type or a production line)

Annex I, Part B is a longer list of 23 categories, covering equipment such as:

• Circular saws
• Hand-fed planing and moulding machinery
• Band-saws
• Portable chainsaws
• Cold-metal presses
• Plastics and rubber moulding machinery
• Underground mining machinery
• Refuse-collection trucks
• Devices for lifting people more than 3 metres
• Presence-detection protective devices
• Power-operated interlocking movable guards
• Logic units for safety functions
• Roll-over protective structures (ROPS)
• Falling-object protective structures (FOPS)

For Part B categories, manufacturers can choose:

• Self-certification, where the product is designed and built entirely in accordance with the relevant harmonised standards or common specifications covering all the applicable essential health and safety requirements
• Or, where it isn't (or no such standards fully cover it), one of the same three routes required for Part A

What documentation do you need?

• EU Declaration of Conformity: For machinery and related products, drawn up once compliance with the essential health and safety requirements has been demonstrated. It can be provided digitally, but must stay accessible online for the product's expected lifetime and at least 10 years after it's placed on the market or put into service.
• EU Declaration of Incorporation: The equivalent document for partly completed machinery, drawn up once compliance with the relevant essential health and safety requirements has been demonstrated in the technical documentation. The same minimum 10-year online accessibility applies.
• Technical documentation: Manufacturers of machinery, related products, and partly completed machinery must each compile technical documentation sufficient to demonstrate compliance. Authorised representatives must be able to keep this on file and produce it for market surveillance authorities for at least 10 years after the product is placed on the market.
• Instructions for use: These must cover the manufacturer's details, a description of the product and its intended use, assembly and installation instructions, residual risks and required protective measures, stability and maintenance information, what to do in the event of a breakdown, and noise or radiation data where relevant thresholds are exceeded.

If any of the above are provided digitally, the manufacturer must mark how to access them, allow users to print, download and save them, and keep them accessible online for at least 10 years.

A free paper copy must still be sent within one month if requested at the time of purchase, and safety information for non-professional users must always be supplied on paper.

How does the Machinery Regulation fit into CE marking regulations?

Many machines fall under more than one EU directive. And the Machinery Regulation doesn’t cover all safety or performance aspects of a product.

For example, equipment may also fall under the Low Voltage Directive or the EMC Directive, as well as the Machinery Regulation.

In these cases, the manufacturer must:

• Identify all applicable directives based on the product type, intended use, and environment
• Ensure the product meets the essential requirements of each directive, which may include safety, energy efficiency, or hazardous substance restrictions
• Compile a single technical file that covers the conformity assessment evidence for all applicable directives
• Draft a single Declaration of Conformity (DoC) that references each relevant directive and harmonised standard
• Affix the CE mark, which symbolises compliance with all relevant EU legislation, not just one

Note that, the CE mark does not indicate conformity with a single directive. It represents compliance with all EU legislation applicable to the product.

Download our free guide here for more information on complying with CE regulations.

Comply with the Machinery Regulation with confidence

Our start-to-finish Machinery Safety Testing service for large and medium-sized capital equipment covers every step of the process, from testing against the essential health and safety requirements to compiling your technical documentation and addressing remedial actions.

Head to our Machinery Safety Testing service page here to find out more.