Is your machine in scope of the EU Machinery Regulation, and can you still self-certify?
From 20 January 2027, Regulation (EU) 2023/1230 replaces the Machinery Directive. Tell us the machine, your role and whether standards cover it, and get a report that names your conformity route, the documents you must hold, and whether a notified body is now mandatory.
- Regulation
- (EU) 2023/1230
- Applies in
- days
- Output
- Cited PDF, 8 to 12 pp.
- Every claim
- Article-cited
A conformity determination for one machine, cited to the Regulation.
Regulation (EU) 2023/1230 runs to well over a hundred articles and several annexes. The report answers the three questions an engineer actually needs before the date, then hands you the documentation set and a dated action list.
Is it in scope
Whether the machine you describe is machinery or a related product under the Regulation, the scope article, and the exclusions to check.
High-risk classification
Whether the machine falls in Annex I Part A, Part B or neither, with the category text and what that classification forces.
Your conformity route
Internal production control, EU type-examination, full quality assurance or unit verification, tied to your category and standards answer.
Documentation you must hold
Technical file, EU declaration of conformity, CE marking, and instructions, including the digital-versus-paper rule.
What changed vs 2006/42/EC
A before-and-after tailored to your category, from the lost self-declaration option to digital instructions and substantial modification.
Transitional rules
The 20 January 2027 application date, the no-dual-window rule, and what happens to machinery already on the market.
Cybersecurity and AI
Where the Regulation's essential requirements on protection against corruption and self-evolving safety functions apply to your category.
Operator duties
Your duties as manufacturer, importer, distributor, authorised representative or integrator, and the deeming rule that can make you the manufacturer.
Dated action checklist
Concrete, dated steps to be ready by 20 January 2027, from engaging a notified body to re-issuing your declaration of conformity.
Three inputs in, a determination out.
Describe the machine
A short label for the machine, plus a category picker keyed to Annex I Part A and Part B, and your operator role. No account.
Answer the coverage question
Whether harmonised standards fully cover the machine's risks. This is the fork that decides self-assessment versus a notified body for Part B.
Get your PDF
A determination the moment you pay: scope, Annex I part, conformity route and Article 25 reference, documentation set and a dated checklist.
Tell us about the machine
Four fields. The report reflects exactly what you enter and confirms the scope article you should check.
What you are buying
When does the EU Machinery Regulation apply?
Regulation (EU) 2023/1230 applies from 20 January 2027. It was adopted on 14 June 2023 and published in the Official Journal on 29 June 2023. From 20 January 2027 it replaces the Machinery Directive 2006/42/EC.
Does it replace the Machinery Directive 2006/42/EC?
Yes. Regulation (EU) 2023/1230 repeals and replaces Directive 2006/42/EC from 20 January 2027. There is no dual-application window: from that date new placings on the market must comply with the Regulation.
Do I have to re-certify machines I already sold before 20 January 2027?
No. "Placed on the market" means the first making available of an individual unit. A machine placed on the market before 20 January 2027 is dealt with under the Directive, so a unit already sold does not need to be re-assessed. Confirm the exact transitional wording against the final chapter of the Regulation for your case.
Which machinery needs a notified body under the Regulation?
Machinery listed in Annex I Part A always needs a notified body (Article 25(2)); you cannot self-declare. Annex I Part B machinery needs one unless harmonised standards cover all the relevant health and safety requirements (Article 25(3)). Machinery not listed in Annex I can use self-assessment by internal production control.
What is the difference between Annex I Part A and Part B?
Annex I replaces the old Annex IV of the Directive and is split into Part A and Part B. Part A is the stricter set: a notified body is always involved and you cannot self-declare. Part B allows self-assessment only where harmonised standards fully cover the risks; otherwise a notified body route applies.
Can I still self-certify with harmonised standards?
For machinery not listed in Annex I, yes, using internal production control. For Annex I Part B, only if harmonised standards cover all the relevant requirements. For the six Annex I Part A categories, no: applying harmonised standards no longer gives you the self-declaration option it did under the Directive.
Are digital instructions for use allowed now?
Yes, and this is a real change. Instructions for use and the EU declaration of conformity may be supplied in digital form where the manufacturer's risk assessment supports it. On request you must supply a paper version free of charge within one month, and safety information for non-professional use must still be provided on paper. Confirm the exact Annex III clause and retention period against the final text.
What counts as a substantial modification, and what happens if I make one?
A substantial modification is a change made after the machine was placed on the market, not foreseen by the manufacturer, that creates a new hazard or increases an existing risk so that new safeguards are needed. Whoever makes such a modification is treated as the manufacturer of the modified machine and takes on the full manufacturer obligations.
What documents must accompany a machine?
The technical documentation (technical file), the applicable conformity assessment, a drawn-up and signed EU declaration of conformity, the CE marking, and instructions for use and safety information. This is the same CE-marking spine as the Directive, restated in the Regulation.
What are my duties if I import or distribute machinery rather than make it?
Importers must place only compliant machinery on the EU market and verify that the manufacturer carried out the conformity assessment, drew up the technical file and declaration of conformity and affixed the CE marking. Distributors verify that the CE marking, declaration of conformity and instructions are present in the required languages. If you place machinery on the market under your own name or trademark, or modify it in a way that could affect compliance, you are treated as the manufacturer.