EU Machinery Regulation 2023/1230: What Changes for Machine Builders in 2027

If you design special machines, you have been living with the Machinery Directive 2006/42/EC your whole career: risk assessment per ISO 12100, essential requirements in Annex I, a technical file, a declaration of conformity, a CE plate. On 20 January 2027 the Directive is repealed and Regulation (EU) 2023/1230 applies in its place, everywhere in the EU, with no national transposition and no overlap period.

Most of what you do stays the same. What changes touches the design office directly: modifications made to your machine, the format of the manual, cybersecurity and software in the essential requirements, and a short list of machines that can no longer be self-certified.

Directive vs Regulation: what actually changes

A directive is transposed into each national law; a regulation applies as written in all 27 member states. The technical content is about 90% the same, often written in more detail. Where to look when you open the new text:

Machines built for your own production are in scope

A common belief in factories: "we don't sell this machine, so CE doesn't apply." It does. The Directive already defined the manufacturer as whoever makes machinery and puts it into service, including for their own use, and the Regulation keeps that definition. The trigger is not the sale but the putting into service: the first use for its intended purpose. An assembly cell built for your own line needs the same risk assessment, technical file, declaration and CE marking as one you would sell. For most machines that is still self-certification: no notified body, you sign. The obligation is the file behind the signature.

Substantial modification: your customer can become the manufacturer

Under the Directive, "is this retrofit a new machine?" was answered by national guidance. The Regulation defines it: a substantial modification is a change, by physical or digital means, made after placing on the market, not foreseen by the manufacturer, that creates a new hazard or increases a risk so that new protective measures are needed. Whoever makes one takes on the manufacturer's obligations for the modified machine. "Digital means" is the new part: a software change that alters a safety function counts.

Annex III: the essential requirements you'll have to read again

Annex III is the old Annex I, extended. Three additions change how a control system is designed and documented.

Practically, 1.1.9 is the one that touches a conventional machine with a PLC and an HMI. The technical file will need to say how connections are secured, which software versions are safety-relevant, and how the machine logs changes. On an isolated internal network the file is easier to write than with a remote-maintenance modem, but the question must be answered either way. The Regulation does not cite the Cyber Resilience Act; expect notified bodies to.

Annex I Part A: six categories that need a notified body

Under the Directive, Annex IV machines could still be self-certified if built fully to harmonised standards. The Regulation splits that list: Part B keeps the possibility, Part A doesn't. These six categories always go through a notified body (EU type-examination, full quality assurance or unit verification):

1. Removable mechanical transmission devices
2. Guards for removable mechanical transmission devices
3. Vehicle servicing lifts
4. Portable cartridge-operated fixing and other impact machinery
5. Safety components with fully or partially self-evolving behaviour using machine learning, ensuring safety functions
6. Machinery with embedded systems of that kind, not placed independently on the market

Items 1 to 4 are rarely a special machine builder's product. Items 5 and 6 are the ones to watch: a vision system that learns to detect an operator in a zone, used as a safety function, puts the whole machine in Part A.

Digital instructions: allowed, with four conditions

Article 10(7) allows digital operating instructions, on four conditions:

• The machine, its packaging or an accompanying document says how to access them.
• They are printable, downloadable and savable.
• They stay available for the machine's expected lifetime and at least ten years after placing on the market.
• A paper copy is supplied free within one month if the buyer asks at purchase.

For non-professional users, the safety information needed to start and use the machine must still be on paper. For a special machine in a factory, that doesn't apply, but the ten-year availability does: your PDF manual needs a home that outlives your current server.

What doesn't change

Everything you already do well under the Directive keeps its value: the risk assessment per ISO 12100 as the backbone of the technical file, performance levels per ISO 13849-1 or SIL per IEC 62061 to prove a safety function, harmonised standards for presumption of conformity once listed under the Regulation, the CE marking, the declaration of conformity and the declaration of incorporation for partly completed machinery.

What to plan: your templates. Every declaration of conformity, every "Annex I" reference in a risk assessment report, every document citing 2006/42/EC needs updating for machines delivered from 20 January 2027.

The takeaway for the shop floor

Read Annex III once, update your templates, and decide for each open project whether it ships under the Directive or the Regulation. Add three things to the technical file: how connections are protected, which software versions are safety-relevant, which modifications you foresee. And treat the machines you build for your own lines exactly like the ones you would sell: same plate, same file. More designs for people who build the machines in the mechanical engineer collection.

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About the author

Gabriel Weider is a mechanical engineer with 15 years in special machines, CAD, medtech and regulated environments. He still works full-time as an engineer and designs every grabNade shirt. Read his story.