Machinery Regulation (EU) 2023/1230
Key outcomes and what manufacturers must prepare for now
The European Commission’s Machinery Expert Group (MEG) met in April 2026 with significant outcomes for anyone placing machinery on the EU market. This update covers the latest developments on harmonised standards, the official Application Guide, and what your business must have in place before the mandatory compliance deadline of 20 January 2027.
Key milestones
April 2026: Key outcomes
Q3 2026 Expected
Harmonised Standards
The Commission will carry over the vast majority of the approximately 800 existing harmonised standards from the Machinery Directive. A gap analysis is underway on new EHSRs covering AI-based safety functions, cybersecurity, and autonomous behaviour.
The first batch of citations under the Machinery Regulation is expected Q3 2026. Implementing Decision (EU) 2026/546, published 13 March 2026, already updated the standard list under the current Directive as an interim step.
What this means for you
If your machinery complies with current harmonised standards, you will in most cases retain presumption of conformity under the new Regulation. Check restrictions product by product, particularly for digitally connected equipment.
End 2026 Target
Application Guide
The Commission’s Editorial Group and five technical subgroups are advancing the official Guide to the Application of the Machinery Regulation, covering substantial modification, safety functions, AI-based safety, cybersecurity, and digital documentation.
The first concepts are expected June/July 2026. Full publication is targeted for end 2026.
Further MEG updates
High-risk machinery
Data collection is complete on a study that may inform future revisions to the high-risk machinery list.
Outdoor Noise Directive
Physical Declarations of Conformity are no longer mandatory. Digital documentation is now accepted.
Upcoming EU legislation
Updates were provided on the upcoming European Product Act package and the Digital Product Passport.
What changes and why it matters
Key regulatory changes manufacturers and importers should prepare for under the new Machinery Regulation.
Cybersecurity
If your machine connects to a network, you now have explicit legal liability for its cyber resilience. This is new territory for most machinery manufacturers and links directly to the EU Cyber Resilience Act.
AI-based safety functions
Machinery regulations explicitly address AI-powered safety components for the first time, subject to specific conformity assessment requirements.
Substantial modification
The Regulation formally defines substantial modification for the first time. Modifying machinery — including software updates affecting safety functions — may trigger a full new conformity assessment.
Digital documentation
Instructions for use may now be provided digitally. Technical documentation must remain accessible for at least 10 years.
Expanded scope
Products previously outside the Machinery Directive — including connected equipment and software-driven systems — may now require CE marking under the MR.
Importer obligations
Importers bear explicit legal responsibility for ensuring conformity assessment is complete, CE marking is correct, and documentation is in order.
Immediate action
What you should do now
Eight months is less time than it sounds. Confirm whether your products fall within the expanded scope, update your risk assessments to cover cybersecurity and AI, and ensure your technical documentation is MR-ready. Importers must verify supplier conformity: the MR places explicit legal responsibility on you.
Prepare before the deadline
Certification Company guides manufacturers and importers through every stage of CE certification — from initial scope assessment and risk analysis to technical file preparation.
Frequently Asked Questions
Practical answers for manufacturers and importers preparing for Regulation (EU) 2023/1230.
01
What is the difference between the Machinery Directive and the Machinery Regulation?
The core difference is in legal form. A Directive must be transposed into national law by each Member State, which historically led to some variation in interpretation across the EU. A Regulation applies directly and uniformly in all Member States without any national implementation step: what is written in the Regulation is the law, everywhere, from day one.
From 20 January 2027, every machine sold or placed on the EU market must meet the new requirements and carry CE marking based on the Regulation. There are no exceptions and no grace period. If your product was compliant under the Directive, that is not automatically sufficient. Cybersecurity, AI safety functions, digital documentation, and substantial modification all introduce obligations that simply did not exist before.
02
Can I still CE-mark under the Machinery Directive after 20 January 2027?
No. All machinery placed on the EU market from that date must comply with Regulation (EU) 2023/1230.
03
Will current harmonised standards still be valid?
Most will be carried over, with the first MR citations expected Q3 2026. Standards for new requirements — including AI and cybersecurity — are still being developed.
04
What is “substantial modification” and why does it matter?
If you modify existing machinery in ways that meet the Regulation’s criteria — including software updates affecting safety functions — you may be required to carry out a full new conformity assessment.
05
When will the Application Guide be available?
Final publication is expected end 2026. Drafts on AI-based safety functions are expected June/July 2026.