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. Four of the seven grounds of formal non-compliance are documentation failures, and none of them requires a defective machine.
Grounds of formal non-compliance — Article 46(1) 4 of 7 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 absent, false or incomplete
DocumentationAny other administrative requirement in Article 10 or Article 13 not fulfilled
Documentation20 Jan 2027no transition
The Regulation replaces the Directive in full, on the day.
Machinery lawfully placed on the market before that date may continue to be made available, but at 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
Under S.I. 2026/867, machinery meeting the relevant requirements of the Machinery Regulation can be placed on the Great Britain market. Building to the Regulation covers GB, Northern Ireland and the EU from one exercise.
Northern Ireland
Under the Windsor Framework the Regulation applies directly in Northern Ireland from 20 January 2027, and the 2008 Regulations are revoked there.
Exporters
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 gapsmost sets fail here
New in this form, and met by almost nothing in service today.
Digital delivery duties
Article 10(7). 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.
Sales literature is in scope
Annex III 1.7.5. Sales literature must not contradict the instructions on health and safety, and where it describes performance characteristics it must carry the same emissions information. Datasheets and brochures are assessed against the manual, not in isolation.
The manual is part of the technical file
Annex IV Part A. A copy of the instructions is a mandatory element of the technical documentation, so a deficient manual also leaves the technical file incomplete. One shortfall, two separate grounds under Article 46.
Citations cannot be find-and-replaced
Annex XII. The correlation table is not a renumbering. Essential health and safety requirements move to Annex III, 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.
Scopethe line, drawn
We assess the documents and say who carries them. We do not certify anything.
What an assessment covers
- Instructions for use assessed against the Annex III 1.7 contents requirements, item by item
- The supplementary instruction requirements for the machinery category
- A determination of scope and of which party carries the manufacturer obligation
- Article 10(7) delivery and access duties — access marking, print and save, breakdown availability, ten-year hosting, paper on request
- Datasheets and sales literature checked against the manual, as Annex III 1.7.5 requires
- Every citation referencing the old Directive identified, with what it needs to become
What it does not cover
- Selecting or carrying out a conformity assessment route
- Compiling or signing off the technical file
- Drafting or approving the declaration of conformity
- Advising on CE marking decisions
- Legal advice on liability or interpretation
- Anything reserved to a notified body
CorridorIQ is a documentation risk assessment and technical authoring practice. 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. Conformity assessment, technical file compilation and the declaration of conformity remain the responsibility of the manufacturer and its advisers.
Send one product family. We will tell you what sits between the documents.
A non-disclosure agreement is in place before any technical material is received.
- The manufacturer and the product family involved
- Which documents exist, and which are referred to but not held
- Whether this is pre-bind, renewal, a risk improvement condition, or a claim
- Your timescale