17/06/2026
Machinery regulation changes: what it means for machine manufacturers?
The new Machinery Regulation 2023/1230, taking effect in 2027, applies to all machinery and equipment manufacturers selling products in the EU market. It fully replaces the current Machinery Directive as of January 20, 2027. The change introduces new requirements for design, documentation, and responsibility distribution across the supply chain.
Previously, the Machinery Directive left room for national authorities to interpret the directive. The new regulation eliminates this flexibility, as it applies directly in all member states without requiring national implementation.
In practice, this means more harmonized requirements but also stricter market surveillance, since national interpretations no longer serve as a buffer.
Software is now part of the machine definition
One of the most significant changes in the Machinery Regulation 2023/1230 concerns digital systems. Software that controls safety-critical functions is now legally considered part of the machine and subject to the same safety requirements as mechanical components.
If your machinery contains artificial intelligence, autonomous functions, or digital control systems, these must be evaluated, documented, and justified as part of the conformity assessment process.
Software updates to machines in use can also constitute a “significant modification” under the regulation, triggering a new assessment if they alter the machine’s safety profile. Assessment is conducted based on the regulation’s definition and criteria for significant modifications.
High-risk machinery requires third-party assessment
Machinery Regulation 2023/1230 defines certain high-risk machinery categories with stricter conformity assessment procedures and a reinforced role for notified bodies. For these machinery categories, participation by a third party (notified body) in the conformity assessment is mandatory.
This particularly applies to machinery operating autonomously and artificial intelligence applications. If your products fall into these categories, you’ll need to establish cooperation with a notified body before placing products on the market. Building these partnerships takes time, so it’s worth starting well in advance.
Risk assessment belongs at the beginning of design
The new machinery regulation clarifies the role of risk assessment. Risk assessment is not merely a document to complete at the end of a project—it’s a tool that guides the entire design process. Hazards are identified first, then the machine is designed based on these findings.
Technical documentation must tell a coherent story: drawings, calculations, safety logic, and justifications for protective measures must be linked so that conformity can be clearly demonstrated.
How the machinery regulation affects CE marking
The basic principle of CE marking doesn’t change: the manufacturer demonstrates conformity, applies the CE mark, and signs the Declaration of Conformity. However, the regulation modifies many practical details of the process for both new and existing machinery.
Impacts on new machinery
The most significant change is that risk assessment and risk reduction must be integrated into design: risk assessment results guide design decisions and are updated as needed during design progression. Risk assessment, in other words, guides every design decision from the start.
Technical documentation grows with the new requirements: alongside assembly and structural drawings, control and circuit diagrams, and operating and maintenance manuals, more detailed documentation of digital systems is required.
The Declaration of Conformity has new content requirements, and certain machinery categories require mandatory third-party assessment.
Impacts on machinery in use
Routine modifications, such as spare part replacement or refurbishment, can still be performed without a new CE process if the machine’s function remains unchanged. The situation changes, however, if the modification is something the manufacturer did not anticipate and creates a new hazard or increases an existing risk. This constitutes a significant modification, whose impact on the existing machine’s or equipment line’s conformity must be assessed case-by-case.
Notably, even a software update can be a significant modification if it changes the machine’s safety profile. If an existing machine receives a new CE mark, the whole system must fully comply with all requirements of the current machinery regulation. Partial updates are insufficient—the entire machine is assessed as new.
Begin preparations early
The new Machinery Regulation applies from January 20, 2027 onward, meaning every machine placed on the market must fully comply with the new requirements. Standards supporting the regulation will be updated further, but this is not a reason to wait.
A good starting point is to review your current product portfolio and documentation in light of the new regulation. What needs updating? Which machines fall under mandatory third-party assessment? Where are there gaps?
At Elomatic, we help machinery and equipment manufacturers meet Machinery Regulation requirements and navigate the CE marking process. Contact us and we’ll explore together what this change means for your products.
Questions and answers about the machinery regulation
The Machinery Regulation applies to all manufacturers of machines and equipment that place their products on the EU market after January 2027. The old Machinery Directive is no longer sufficient. Importers and distributors of machinery also have their own obligations under the new regulation.
Machines placed on the market before January 2027 remain under the old Machinery Directive. The requirements of the new regulation apply to machines placed on the market on or after 20 January 2027. If a significant modification is made to a machine after this date, conformity must be reassessed.
A significant modification means a physical or digital change that creates a new hazard in the machine or increases an existing risk, substantially affects the safety of the machine, and requires the addition of guards or protective devices.
This often requires modifying a safety-related control system or implementing additional protective measures to ensure stability or mechanical strength. Such a modification may trigger an entirely new conformity assessment process. The boundary is not always clear, so modifications should be carefully documented and assessed with an expert.
For most machine categories, yes — compliance with a harmonised standard still helps demonstrate conformity. However, for six particularly high-risk product categories, it is no longer sufficient: these also require mandatory third-party inspection. Standards will also be updated in line with the new regulation.
Software controlling safety-critical functions is now legally part of the machine. It must be assessed, documented, and justified as part of the conformity assessment process. This also applies to updates: if a software update changes the safety profile of the machine, it may trigger a new assessment.
The best starting point is a current state assessment: review your product range in light of the new regulation and identify which machines require changes, which fall within the scope of mandatory inspection, and where there are gaps in documentation. Elomatic’s experts can help with this assessment — get in touch and we’ll review the situation together.
Submit a quotation request
Request an Expert Assessment of the Machinery Regulation’s Impact
- We assess your situation and explain what the Machinery Regulation 2027 means for your specific products.
- A no-obligation quote: you receive a clear proposal outlining the timeline, price, and scope of the assessment.
