Machinery Regulation 2023/1230: What’s Changing in 2027

Regulation (EU) 2023/1230 on machinery will replace the Machinery Directive 2006/42/EC on January 20, 2027. It sets forth the health and safety requirements that must be met by machinery, related products, and partly completed machinery placed on the market in the European Union. As a regulation rather than a directive, it applies directly in France without the need for transposition.

You may have read that this text applies only to manufacturers, but in fact, it goes further than that. Indeed, a company that modifies its own machines may legally become the manufacturer of those machines.

With three months to go until the deadline, here’s what you need to know.

What are the key dates for the Machinery Regulation?

The regulation took effect in 2023, and most of its requirements do not apply until 2027.

Machinery placed on the market in accordance with the directive before January 20, 2027, does not need to be reevaluated. The regulation applies to machinery placed on the market on or after that date and to subsequent modifications made to existing machinery.

Substantial Modification: When Do You Become a Manufacturer?

Article 18 of the regulation is the one that surprises industrial sites the most. Any person who makes a substantial modification to a machine is considered to be its manufacturer. It then sets forth all the requirements of Article 10: conformity assessment, technical documentation, EU Declaration of Conformity, and CE marking.

The regulation (Article 3, point 16) defines a substantial modification based on four criteria:

1. it takes place after the product has been placed on the market or put into service;
2. it is carried out using physical or digital means;
3. it was neither intended nor planned by the manufacturer;
4. it creates a new hazard or increases an existing risk to the point of requiring protective measures affecting the safety control system, or measures related to stability or structural strength.

Examples of such cases include adding a robot to a production line, linking two machines, modifying the safety zones of a laser scanner, or updating the software of a safety controller. Repair and maintenance operations that do not affect the machine’s compliance are not included.

The hardest part isn’t applying the definition; it’s figuring out who in your organization decides whether a change is substantial. At most sites, no one is assigned to handle this issue.

Cybersecurity: What Are the New Requirements for Machines?

For the first time, protection against malicious acts is becoming an essential requirement for machine safety. The 2006 directive did not address this issue.

Section 1.1.9 of Annex III requires that:

• protect software, data, and communication components essential to security against corruption, whether accidental or intentional;
• Identify the software required for the safe operation of the machine;
• Keep a record of any changes—whether legitimate or not—made to this software or its configuration.

Section 1.2.1 requires that control systems be resistant to reasonably foreseeable malicious attempts by third parties.

These requirements align with the Cyber Resilience Act (Regulation (EU) 2024/2847), which governs digital components, and with the NIS 2 Directive, which your customers may incorporate into their specifications. The harmonized standard EN 50742, dedicated to protection against corruption, is currently being developed. In the meantime, the UNM recommends relying on ISO/TR 22100-4 and the IEC 62443 series.

Machines and Artificial Intelligence: What the Regulation Says

The regulation applies to systems with “fully or partially self-adaptive behavior” that use machine learning. When these systems perform a safety function, assessment by a notified body becomes mandatory (Annex I, Part A, points 5 and 6), even if the manufacturer applies harmonized standards. The regulation also prohibits any machine-generated changes to settings—including during the learning process—if such changes could create a hazardous situation.

The UNM guide published in 2025 provides a useful clarification: as of the date of its publication, no AI system was capable of performing a safety function validated according to recognized methods. AI that sorts parts or optimizes a path is considered a standard function. AI that retracts a blade when a hand approaches is considered a safety function.

What did the July 2026 AI Omnibus Act change?

Regulation (EU) 2026/1744 of July 8, 2026, establishes the Machinery Regulation as the single compliance framework for AI embedded in machinery. Prior to this amendment, a machine incorporating high-risk AI was subject to both the Machinery Regulation and the AI Act.

In practical terms:

• Machines are no longer subject to the direct application of the AI Act; theregulations governing machines are transferred from Section A to Section B of Annex I of the AI Act.
• The requirements of the AI Act will be incorporated into Annex III of the Machinery Regulation: data governance, documentation, human oversight, and risk and quality management. The Commission will adopt them through delegated acts, which will take effect no later than August 2, 2028.
• Pending the adoption of machine-specific standards, compliance with the harmonized standards of the AI Act constitutes a presumption of conformity.
• Existing evaluation procedures will remain in place. The presence of AI alone does not trigger the involvement of a notified body.

The date of January 20, 2027, and the cybersecurity requirements remain unchanged.

What about Switzerland?

The Machinery Ordinance (OMach) still refers to Directive 2006/42/EC. On September 19, 2025, the Federal Council launched a consultation on a complete revision of the ordinance in order to transpose the European regulation in an equivalent manner and to preserve the mutual recognition agreement with the EU. Swiss companies that export to the EU will be subject to the European regulation starting in January 2027.

How Novallia Supports You

Novallia assists industrial companies with regulatory compliance in France and Switzerland. With regard to the Machinery Directive, the nature of our support depends on your specific situation.

You use machines.

• We are compiling a list of the changes that have been made or are planned for your fleet,
• We define the resulting obligations

You manufacture machines.

We work with you to conduct a comprehensive assessment of your compliance:

• classification of your machines in accordance with Annexes I and II (high-risk machines, safety components, AI);
• review of your risk analysis in light of the new essential requirements;
• Validation of your technical files, declarations of conformity, and instructions for use, including in digital format;
• Identification of cases in which the involvement of a notified body becomes mandatory.

With NV Compliance, our regulatory monitoring and compliance platform, you’ll receive alerts about changes to the text—including future delegated acts on AI—and manage your compliance action plans.

Contact our experts

Frequently asked questions

When does Regulation (EU) 2023/1230 on machinery apply?

👉 January 20, 2027. It entered into force on July 19, 2023, and replaces Directive 2006/42/EC as of that date.

Do existing machines need to be recertified?

👉 No. Machinery placed on the market in accordance with the directive before January 20, 2027, does not need to be reevaluated, unless it undergoes a subsequent substantial modification.

Can a software update constitute a substantial modification?

👉 Yes. The regulation specifies that the modification may be physical or digital, provided it meets the other criteria set forth in Article 3, paragraph 16.

Is the AI Omnibus Act Delaying the Machine Learning Regulation?

👉 No. The date of January 20, 2027, remains unchanged. Only the AI requirements added by delegated acts will take effect later, no later than August 2, 2028.

Sources:
Regulation (EU) 2023/1230;
Regulation (EU) 2026/1744;
INRS, “New Machinery Regulation: What’s New?”;
UNM, Cybersecurity Guide for Machinery (2025) and Practical Guide on the Concept of AI (2025);
Federal Council, press release dated September 19, 2025.