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Machinery Makers: The 2027 Rules to Budget For

Take a workshop that buys a second-hand CNC router and fits a better spindle motor itself. Good engineering, sensible money. Under the rules that apply until January 2027, that modification is the workshop's business. Under the Machinery Regulation that replaces them, a modification like that can legally turn the workshop into the machine's manufacturer — with a conformity assessment, a declaration and a CE mark to match.

Regulation (EU) 2023/1230 applies from 20 January 2027, replacing the Machinery Directive that has governed the sector since 2006. Here's what changes and who it catches.

What's actually new

The regulation keeps the core structure — essential health and safety requirements, CE marking, a declaration of conformity, a technical file kept for ten years — but changes some things that matter:

Digital documentation. Paper manuals are no longer the default. Instructions may be supplied digitally, provided the customer can still request a paper copy free of charge, and the technical file can be maintained in digital form. Small manufacturers gain time and print costs here.

"Substantial modification" creates a new machine. This is the headline change. If someone modifies a machine so significantly that it becomes, in legal terms, a new machine, that person becomes the manufacturer and must carry out a full conformity assessment before it's put into service. Retrofits, re-equipping, adding a new control system — the line is functional change and new risk, not the age of the machine. Second-hand machinery dealers and workshops doing upgrades are the businesses most exposed.

AI safety components. Software that performs safety functions becomes a safety component in its own right, and machines using AI for safety functions must account for it. The AI Act sits on top of this for high-risk applications, which we covered in that guide.

Cybersecurity. Machines with digital elements must be designed so that software changes don't create new hazards — a first for machinery law, and a new cost for anyone whose machine phones home.

The high-risk categories

The regulation rewrites the Annex I list of machines that always require third-party involvement. Power take-off shafts and their guards, vehicle servicing lifts, portable cartridge-operated impact machinery — and, the notable addition, safety components and machinery whose safety systems use self-evolving machine learning. That last entry is where the AI Act and machinery law now overlap, which is why the AI Act guide matters for machine builders. Notably absent from the new list: press brakes, log saws and injection moulding machines, which dropped out of the high-risk tier in the rewrite. Most workshops making standard equipment still self-declare — the same logic as the current directive, which we explained in the CE declaration guide.

What to do before January 2027

If you manufacture or import machinery, three practical steps:

  1. Audit your product range against the new essential requirements. The text changed; your old technical files may not cover cybersecurity or the new documentation rules.
  2. Decide your digital instruction strategy. Digital-first instructions with paper on request is the cheapest compliant path, but the paper-on-request channel must actually exist.
  3. If you modify machines, write down your justification. Document why each modification does or doesn't count as substantial — the analysis itself is your evidence if a market surveillance authority asks. A documented "this doesn't change the safety function" file is far better than silence.

Old certificates keep running until they expire, and machines placed on the market before 20 January 2027 can keep circulating. Anything placed after that date must meet the new regulation. "We've always done it this way" stops being a legal position on that date.

The cost reality for a small workshop

For most small manufacturers, compliance costs stay modest — technical documentation work, a revised declaration, updated manuals. The expensive surprises are the retrofit shops and second-hand dealers who discover they've been manufacturers all along without knowing it.

The same point applies here as in the rest of this series: the deliverable isn't a file in a drawer, it's a document that can be shown and verified. A CE declaration under the new regulation, published as a live page with the technical file references, answers buyers, inspectors and insurers with one link. Sustalium does that for €10 per document — and when the harmonised standards under the regulation are updated, as they will be, you'll see the new version and update once instead of rewriting from memory. January 2027 is one design cycle away. Treat it like one.

How Sustalium Helps Machinery Builders

  • One live declaration per machine — the CE declaration and technical file references, verifiable by buyers, inspectors and insurers.
  • Version updates, not rewrites — when a harmonised standard changes, you see the new version and update once.
  • Documented modification decisions — your "substantial modification" analyses live with the machine record as evidence.

A Machine's Papers Should Live as Long as the Machine

Publish the declaration once, keep it current with each standard update, and show it with a link. Start with a free draft: no card needed, publish the verifiable version when you are ready.

Start Your CE Declaration →

Frequently Asked Questions

When does the Machinery Regulation apply?

From 20 January 2027, replacing the Machinery Directive 2006/42/EC. Machines placed on the market before that date can keep circulating; anything after must meet the new rules.

Does retrofitting make me a manufacturer?

If a modification is substantial — creating a new machine in legal terms — you become the manufacturer and must run a full conformity assessment before the machine is put into service.

Are press brakes still in the high-risk list?

No. The new Annex I removed press brakes, log saws and injection moulding machines. New additions include safety components and machinery using self-evolving machine learning.

Last updated: September 23, 2026

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