Regulation (EU) 2023/1230 · applies 20 January 2027
Your instructions for use are a legal document with a defined contents list.
Under Regulation (EU) 2023/1230, instructions for use must contain specified information, be delivered in specified ways, and stay available for ten years. We write manuals against those requirements. That is the whole of what we do here — the conformity assessment, the technical file and the declaration stay with you and your compliance function.
Why the manual matters — Article 46(1)
4 of 7 grounds are paperwork
CE marking affixed in violation of the marking requirements
MarkingCE marking not affixed
MarkingNotified body identification number wrongly affixed, or not affixed
MarkingEU declaration of conformity not drawn up, or not drawn up correctly
DocumentationTechnical documentation not available or not complete
DocumentationManufacturer or importer identification information absent, false or incomplete
DocumentationAny other administrative requirement in Article 10 or Article 13 not fulfilled
DocumentationThe deadline
20 January 2027. No transition period at the date itself.
The Machinery Regulation replaces Directive 2006/42/EC in full. Machinery lawfully placed on the market before that date may continue to be made available — but on the deadline there is no choice between the old rules and the new. Being a regulation rather than a directive, it applies directly across every member state.
GREAT BRITAIN
A single compliance route
Under S.I. 2026/867, machinery meeting the relevant requirements of the Machinery Regulation can be placed on the market in Great Britain. Building to the Regulation now covers GB, Northern Ireland and the EU from one exercise.
NORTHERN IRELAND
The Regulation applies directly
Under the Windsor Framework the Machinery Regulation applies directly in Northern Ireland from 20 January 2027, and the 2008 Regulations are revoked there.
EXPORTERS
Instructions gate market access
Instructions, safety information and the declaration must be in the language determined by the destination member state. An importer may only place machinery accompanied by them.
Four things most sets fail on
These are new in this form, and almost nothing in service today meets them.
01 · ARTICLE 10(7)
Digital delivery duties
Digital instructions are permitted, but the product must be marked with how to access them; they must be printable, downloadable and savable; they must be accessible during a breakdown; and they must remain online for the expected lifetime and at least ten years. Paper must be supplied free of charge within one month if requested at purchase.
02 · ANNEX III 1.7.5
Sales literature is in scope
Sales literature must not contradict the instructions for use on health and safety, and where it describes performance characteristics it must carry the same emissions information. Datasheets and brochures are audited against the manual — not in isolation.
03 · ANNEX IV PART A
The manual is part of the technical file
A copy of the instructions for use is a mandatory element of the technical documentation. A deficient manual therefore also makes the technical file incomplete — one defect, two separate grounds under Article 46.
04 · ANNEX XII
Citations cannot be find-and-replaced
The correlation table is not a renumbering. The Directive's essential health and safety requirements move to Annex III, but section 1.1.1 splits across two Parts, the old Annex XI becomes an Article, and several Directive articles map to nothing. Automated replacement produces wrong citations.
Scope of the service
We are technical authors. We write the manual, not the compliance case.
The Regulation places duties across design, conformity assessment, marking, technical documentation and instructions. Only the last of those is a writing job, and it is the only one we take on. Being clear about the line protects you as much as us.
WE DO
The documents
- Assess instructions for use against the Annex III 1.7 contents requirements, item by item
- Check the supplementary instruction requirements for your machinery category
- Rewrite or restructure the manual to meet them
- Check the delivery and access duties under Article 10(7) — access marking, print and save, breakdown availability, ten-year hosting, paper on request
- Check datasheets and sales literature against the manual, as Annex III 1.7.5 requires
- Identify every citation in the set that references the old Directive and list what it needs to become
WE DO NOT
The compliance case
- Decide whether your product is in scope, or which Annex I category it falls in
- Select or carry out a conformity assessment route
- Compile or sign off the technical file
- Draft or approve the declaration of conformity
- Advise on CE marking decisions
- Give legal advice on obligation, liability or interpretation
One thing worth knowing
The manual is part of the technical file, so a weak manual weakens both.
Annex IV Part A lists a copy of the instructions for use as a mandatory element of the technical documentation. So instructions that fall short of Annex III 1.7 also leave the technical file incomplete — the same shortfall reaching two separate grounds under Article 46.
That is the argument for getting the manual right, and it is also the limit of our involvement. We can make the instructions sound. Whether the rest of the file holds together is a question for whoever compiles it.
Send one manual. We will tell you what Annex III asks for that it does not carry.
An item-by-item assessment of the instructions for one product, each finding cited to the clause behind it.
CorridorIQ is a technical authoring service. This page describes instruction and documentation requirements under Regulation (EU) 2023/1230. It is not legal advice, and it is not a conformity assessment or certification service. Scope, classification, conformity assessment, technical file compilation and declaration of conformity remain the responsibility of the manufacturer and its advisers.