Machinery Regulation (EU) 2023/1230: What Changes in 2027

The Machinery Regulation (EU) 2023/1230 replaces the Machinery Directive 2006/42/EC. It was published on 29 June 2023 and applies from 20 January 2027. Because it is a regulation and not a directive, it applies directly in every EU member state. Machines placed on the market from that date must comply with the new text.

For CE marking under the new Machinery Regulation, apply to CE Danışmanı (CE Consultant); we manage the whole process for you.

Timeline

What changes

Software, AI and cybersecurity

Software that performs a safety function, including systems with self-evolving behaviour, is explicitly addressed. Protection of control systems against corruption and cyber-attack becomes part of the essential health and safety requirements, and therefore part of the risk assessment.

High-risk machinery

The list that replaces the old Annex IV has changed. For the categories in Annex I, Part A, the involvement of a notified body is mandatory. For the categories in Part B, the manufacturer may still self-assess when harmonised standards are applied in full.

Digital documentation

Instructions for use and the declaration of conformity may be provided digitally. If the buyer asks, a paper copy must be supplied free of charge.

Substantial modification

If a machine is modified after it has been placed on the market and the change falls under the definition of “substantial modification”, the machine must undergo conformity assessment again. Whoever makes the modification takes on the obligations of a manufacturer.

Clearer rules for partly completed machinery

Partly completed machinery remains in scope, with more precise rules on documentation and the declaration that accompanies it.

What stays the same

• The logic of risk assessment and risk reduction (EN ISO 12100)
• The technical file and the declaration of conformity as the core documents
• CE marking affixed visibly, legibly and indelibly
• Self-declaration as the route for most machines

Obligations of manufacturers

• Carry out the risk assessment and apply the necessary protective measures
• Compile the technical documentation and keep it for 10 years
• Complete the applicable conformity assessment procedure
• Draw up the EU declaration of conformity and affix the CE marking
• Provide instructions and safety information in the language of the country of use
• Put name, registered trade name or trade mark and contact address on the machine
• Monitor products on the market and take corrective action, including recall, when a safety problem appears
• Address the security of digital components and software updates

Obligations of importers

• Verify that the machine bears the CE marking and is accompanied by the EU declaration of conformity
• Verify that the manufacturer has drawn up the technical documentation
• Put their own name and contact address on the machine, its packaging or the accompanying documents
• Ensure instructions are available in the required language
• Keep a copy of the declaration for 10 years and make the technical documentation available to the authorities on request
• Inform the manufacturer and the authorities about machines that present a risk

What to do before January 2027

1. Check the category. Is your machine listed in Annex I, Part A or Part B?
2. Review the risk assessment for software, connectivity and cybersecurity.
3. Update the technical file and the declaration template to the new references.
4. Decide how instructions will be delivered, digitally or on paper.
5. Plan notified body capacity early if your machine is in Part A.

Machinery made in Turkey

Turkey aligns its machinery legislation with the EU. Machine builders in Turkey that export to the EU, and buyers of machinery made in Turkey, should plan for the new requirements now. See also Machinery CE marking.