Machinery Regulation (EU) 2023/1230: No Harmonised Standards Yet, Twelve Weeks Before 20 January 2027

On 20 January 2027, the Machinery Regulation (EU) 2023/1230 replaces the Machinery Directive 2006/42/EC. Twelve weeks before that date, not a single harmonised standard has been cited in the Official Journal under the new Regulation. This article explains why that matters, which machinery is most affected, and what manufacturers and importers can prepare now.

What changes on 20 January 2027

The Machinery Regulation applies directly and identically in all Member States. It keeps the CE marking system but adds new requirements, for example on cybersecurity, AI-based safety functions, digital instructions and the obligations of importers and distributors. The Machinery Directive is repealed on the same day.

The switch is a hard cut-over. The Regulation cannot be applied early, and there is no sell-off period for newly built machines that only comply with the Directive. What counts is the moment each individual unit is placed on the EU market, meaning its first supply for distribution or use in the EU.

Three consequences follow from this:

• Machines placed on the market before 20 January 2027 remain legal and can still be sold through the distribution chain.
• Unsold stock that has only been shipped to an EU warehouse or importer has not yet been placed on the market. From 20 January 2027, it must comply with the Regulation.
• Used machinery imported from a third country counts as new to the EU market and must also comply with the Regulation.

Contract and delivery dates around the deadline are therefore a compliance question, not only a logistics question.

Why harmonised standards matter

Harmonised standards are the most common way to show that a machine meets the essential health and safety requirements. A machine built in line with a harmonised standard whose reference is published in the Official Journal benefits from a presumption of conformity under Article 20(1) of the Regulation, for the requirements that standard covers.

This presumption only applies to standards cited under the Machinery Regulation. Standards cited under the Machinery Directive do not confer it, even if their content is identical.

Where the standards stand in October 2026

More than 800 harmonised standards are currently cited under the Machinery Directive. The Commission sent its standardisation request for the new Regulation to CEN and CENELEC in January 2025. A first implementing decision citing standards under the Regulation is expected before the end of 2026, and the Commission plans to carry over the vast majority of the existing standards.

Until that decision is published, there is no presumption of conformity under the new Regulation. The Commission continues to update the list under the Directive, most recently with Implementing Decision (EU) 2026/2015 of 7 September 2026, which added standards for industrial robots, autonomous agricultural machinery and additive manufacturing. These updates help during the transition, but they do not create a presumption of conformity under the Regulation.

Where no suitable standards exist, the Commission can adopt common specifications by implementing act as a fallback.

What the gap means for high-risk machinery

The old Annex IV list of high-risk machinery becomes Annex I of the Regulation, split into two parts. The standards gap affects them differently.

Category	Conformity assessment from 20 January 2027	Effect of the standards gap
Annex I Part A (6 categories, including new categories for machine-learning-based safety functions)	Notified body always required (Article 25(2))	None. A notified body is needed in any case.
Annex I Part B (19 categories, largely the old Annex IV list)	Self-assessment possible if harmonised standards cited under the Regulation or common specifications are applied in full (Article 25(3))	As long as no standards are cited, a notified body is needed.
Other machinery	Self-assessment (internal production control)	No presumption of conformity until standards are cited. The risk assessment has to justify how each requirement is met.

Part B is where the gap has the clearest practical effect. Manufacturers who have relied on self-assessment with harmonised standards under the Directive may need a notified body for units placed on the market from 20 January 2027, unless the first citations arrive in time. Notified body capacity around the deadline is expected to be tight.

Other changes to check before the deadline

The standards gap is not the only point to prepare for. Several other changes affect the technical file and the conformity process:

• Cybersecurity as a safety requirement. Machinery with digital interfaces must be protected against corruption, so that safety functions cannot be compromised by a third party.
• Digital instructions. Instructions may be supplied digitally for the first time. They must be printable and remain accessible for the expected lifetime of the machine and at least ten years. Paper instructions must be provided free of charge on request at the time of purchase.
• Substantial modification. Whoever substantially modifies a machine already in service, physically or digitally, in a way that creates a new hazard or increases a risk, becomes the manufacturer of the modified machine (Article 18).
• Technical documentation and declaration. The technical file now follows Annex IV of the Regulation and can include the programming logic of safety-relevant software on request of a market surveillance authority. The EU declaration of conformity follows Annex V and can be supplied digitally.

Penalties: Member States had to report by 20 October 2026

Under Article 50 of the Regulation, Member States had to lay down their rules on penalties for infringements and notify them to the Commission by 20 October 2026. Germany has done so with the Machinery Law Implementation Act (MaschinenDG), which applies from 20 January 2027. Penalties must be effective, proportionate and dissuasive.

What manufacturers and importers can prepare now

The following steps can be taken without waiting for the first citations:

1. Check the Annex I classification. Determine for each machine type whether it falls under Part A, Part B or neither. For Part B machinery, clarify early whether a notified body will be needed and contact one in time.
2. Run a gap analysis. Compare the current conformity process under the Directive with the requirements of the Regulation: essential requirements, conformity route, technical file content and declaration template.
3. Document the risk assessment carefully. Without a presumption of conformity, the risk assessment has to show how each essential requirement is met. Cybersecurity risks and, where relevant, AI-based or autonomous functions should be added.
4. Plan deliveries around the cut-over. Units placed on the EU market before 20 January 2027 can follow the Directive. Units placed later need Regulation conformity, including stock already held by EU importers.
5. Involve the supply chain. Importers and distributors have explicit obligations under the Regulation and will ask for updated declarations and documentation. Component suppliers will need to provide information for the new technical file.
6. Monitor the Official Journal. The first citation decision under the Regulation can change the conformity route for Part B machinery at short notice.

How ArtemLEX supports machinery manufacturers

ArtemLEX includes a module for the Machinery Regulation and CE marking. Its legal database is updated daily from the Official Journal of the European Union, so new citations of harmonised standards can be taken into account as soon as they are published.

For each product group, the platform determines which regulations and standards apply and checks the technical documentation for completeness. Supplier documents, such as test reports and declarations for components, can be requested through a personal link and are checked when they are uploaded. For manufacturers without their own EU entity, ARTEM can act as EU authorised representative.

The assessment of whether a machine complies, and which conformity route to take, stays with the manufacturer and, where required, the notified body. ArtemLEX prepares that assessment and makes it traceable.

Some important FAQs

Are there harmonised standards under the Machinery Regulation yet? No. As of October 2026, no harmonised standard has been cited in the Official Journal under Regulation (EU) 2023/1230. A first citation decision is expected before the end of 2026.

Do standards cited under the Machinery Directive give a presumption of conformity under the Regulation? No. Only standards whose references are published in the Official Journal under the Machinery Regulation give a presumption of conformity under Article 20(1).

Does Annex I Part B machinery need a notified body from 20 January 2027? Self-assessment is only possible if harmonised standards cited under the Regulation, or common specifications, are applied in full. As long as none are cited, Part B machinery needs a notified body.

Can machines built under the Directive still be sold after 20 January 2027? Only if the individual unit was placed on the EU market before that date. Unsold stock that has not yet been supplied for distribution or use in the EU must comply with the Regulation.

Conclusion

The Machinery Regulation applies from 20 January 2027 without a transition period for new machines. Twelve weeks before that date, harmonised standards under the Regulation are still missing, and with them the presumption of conformity. For most machinery, this means a more detailed risk assessment. For Annex I Part B machinery, it can mean a notified body where self-assessment was possible before. The first citation decision is expected before the end of 2026, but planning should not depend on it.

Key facts

• The Machinery Regulation (EU) 2023/1230 applies from 20 January 2027 and repeals the Machinery Directive 2006/42/EC.
• There is no sell-off period. What counts is when each unit is placed on the EU market.
• As of October 2026, no harmonised standard has been cited under the Regulation. More than 800 are cited under the Directive.
• Standards cited under the Directive do not give a presumption of conformity under the Regulation.
• Annex I Part A machinery always needs a notified body. Annex I Part B machinery needs one as long as no standards are cited under the Regulation.
• Member States had to notify their penalty rules to the Commission by 20 October 2026.