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Notified Body or self-certification?

Most machinery does not need a Notified Body. And being on the Annex IV list does not, by itself, mean yours does.

That second sentence is the one worth stopping on. It is reported wrong almost everywhere — in supplier checklists, in procurement templates, in the advice a European customer passes on in good faith. The consequence is expensive in both directions: manufacturers who buy third-party assessment they never needed, and manufacturers who discover, weeks before shipping, that they did.

Here is the actual rule.

The rule today, under the Machinery Directive

Three cases. Find yours.

Case 1 — your machine is not in Annex IV. Self-assessment. You apply the internal-checks procedure, assemble the technical file, sign the Declaration, affix the mark. No Notified Body is involved at any point. This is most industrial machinery, and if you build packaging lines, assembly systems, process equipment, material handling or custom automation, this is almost certainly you.

Case 2 — your machine is in Annex IV, and you built it fully to harmonised standards that cover all the relevant health and safety requirements. Self-assessment is still permitted. You may choose to involve a Notified Body — EC type-examination, or a full quality assurance system — but you are not obliged to. The Directive gives you all three routes and lets you pick.

Case 3 — your machine is in Annex IV, and it was not built fully to those standards — or the standards do not cover every relevant requirement, or none exist for your machine. Now a Notified Body is required. Two routes: EC type-examination, or a full quality assurance system.

Fact — check it yourself

The trap is treating Annex IV as the whole test. It isn’t.

Annex IV tells you which question to ask next; the standards you built to give the answer.

Directive 2006/42/EC, art. 12(3)(a)(b)(c)

What is actually on Annex IV

Twenty-three categories, and they are far more specific than most people expect. In broad groups:

  • Woodworking machinery — circular saws, planers, thicknessers, band saws, tenoning machinery, spindle moulders, portable chainsaws, and combinations of these (categories 1–8).
  • Presses for cold metalworking, including press brakes, with manual loading or unloading, above a defined travel and speed (category 9).
  • Injection and compression moulding machinery for plastics and rubber, with manual loading or unloading (categories 10–11).
  • Underground machinery — locomotives, brake vans, hydraulic-powered roof supports (category 12).
  • Refuse collection trucks with a compression mechanism, manually loaded (category 13).
  • Removable mechanical transmission devices and their guards (categories 14–15).
  • Vehicle servicing lifts (category 16).
  • Devices for lifting persons where the fall hazard exceeds three metres (category 17).
  • Portable cartridge-operated fixing and impact machinery (category 18).
  • Safety components — presence-detection protective devices, power-operated interlocking movable guards for the machinery in categories 9–11, logic units for safety functions, ROPS and FOPS (categories 19–23).

Fact — check it yourself

If your machine is not described by one of these, you are in Case 1.

Note that several entries are safety components, not complete machines — if you manufacture and sell a safety component on its own, the list applies to you even though you do not build machinery.

Directive 2006/42/EC, art. 12(2) · Annex IV, points 19-23

What changes on 20 January 2027

The Regulation reorganises the list and, for the first time, creates a group where you cannot self-assess at all.

The twenty-three Annex IV categories become twenty-five, split in two:

Part A — six categories. A Notified Body is mandatory, whatever standards you built to.

  1. Removable mechanical transmission devices, including their guards
  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 approaches to ensure safety functions
  6. Machinery with embedded systems of that kind, not placed independently on the market — for those systems only

Part B — nineteen categories. The current logic continues: internal control is available only if you design and build to the harmonised standards or common specifications covering all the relevant requirements for that category. Otherwise, EU type-examination, full quality assurance, or unit verification.

Not listed in Annex I at all? Internal production control. Same as today.

Read the change precisely. Four categories — removable mechanical transmission devices, their guards, vehicle servicing lifts, and portable cartridge-operated fixing machinery — move from “self-assessable if you use harmonised standards” to “third party, always.” If you make any of these and self-assess today, your route disappears on 20 January 2027. The other two Part A categories are new: they exist because a safety function that learns cannot be validated once and left alone.

Fact — check it yourself

On the date: the Official Journal text says 14 January 2027.

It is a clerical error, corrected to 20 January by a corrigendum. The uncorrected version is still in circulation.

Reg. (EU) 2023/1230, art. 54 · corrigendum OJ L 169/35, 4.7.2023

Choosing a route when you have a choice

In Case 2 you may self-assess but are not required to. Three things that should push you toward a Notified Body even when the law does not:

  • Your customer’s procurement asks for it. Contractual, not legal — but no less binding on you.
  • You are exposed to a market surveillance authority you have not dealt with before. A type-examination certificate is a shorter conversation than a technical file.
  • You cannot demonstrate full coverage by harmonised standards. If honest scrutiny of your own file leaves gaps, Case 2 has quietly become Case 3.

Fact — check it yourself

And one that should push you away: the belief that a Notified Body transfers your liability.

It does not. You still sign the Declaration. You still hold the file. You still answer for the machine.

Directive 2006/42/EC, Annex II, 1.A.10 · Reg. (EU) 2023/1230, art. 10

How we work this question

It is the first thing we answer, and we answer it before you commit to anything, because it determines both your cost and your schedule. What we need to give you a firm answer is small: what the machine does, what it is called in your catalogue, which standards you designed to, and where in Europe it is going.