EU Machinery Regulation, answered.
The questions manufacturers, importers and integrators ask most about Regulation (EU) 2023/1230, with the article behind each answer. General information, not legal advice. Verified as at 12 July 2026.
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.
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.
Get this decided for your machine
The report screens one machine against Regulation (EU) 2023/1230 and returns whether it is in scope, its Annex I part, the exact conformity route with the Article 25 reference, and the documents you must hold before 20 January 2027.
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