With the new European Union Machinery Regulation, software becomes just as important for machine safety as mechanics and electrical systems. This brings practical changes for manufacturers in design decisions, cybersecurity solutions, and the logic of conformity assessment, writes Kristo Klementi, Member of the Management Board at Revismo and Head of CE Compliance.
In less than a year, on 20 January 2027, the Machinery Regulation (EU) 2023/1230 will apply in full. The Regulation replaces the Machinery Directive 2006/42/EC, which will cease to apply on the same date. From that point, manufacturers must ensure that their products fully comply with the requirements of the new Regulation.
Definition of a Manufacturer and the Scope of the Machinery Regulation
Under the Machinery Regulation, a manufacturer is a natural or legal person who:
a) manufactures products that fall within the scope of the Regulation, or has them designed or manufactured, and markets them under their name or trademark
b) manufactures products that fall within the scope of the Regulation and puts them into service for their own use.
The scope of the Machinery Regulation (as well as the current Machinery Directive) covers a very large share of machinery and related products produced in Estonia and across Europe. This includes everything from production equipment and lifting machinery to safety components, interchangeable equipment, and partly completed machinery.
In practice, this means that most companies that manufacture, design, integrate, or distribute machinery will be affected by the Regulation directly or indirectly. The impact is not limited to documentation. It also affects design decisions, software, safety, and conformity assessment. In other words, the Regulation will have a real and broad impact on manufacturers.
Below are some of the larger changes the new Regulation introduces.
- The definition of “machinery” is updated
An important change starts with what is considered machinery and what falls within the scope of the Regulation. Compared to the Directive, the Regulation also treats as machinery a product that is otherwise complete but is missing only the manufacturer’s intended software.
This means that, from a safety perspective, software is treated as just as important as the mechanical and electrical parts. For the manufacturer, this brings additional obligations related, among other things, to ensuring cybersecurity, protecting source code, and the content of the technical file.
- The concept of a “substantial modification” is clearly defined
In practice, there are cases where machinery placed on the market is modified. The Machinery Directive did not clearly define when a change is “substantial” in a way that shifts responsibility and the obligation to perform conformity assessment from the original manufacturer to the party making the change. The Regulation is more specific and clearly defines what a substantial modification is.
In summary, a substantial modification is a physical or digital change made after placing on the market that the manufacturer did not foresee and that affects safety or increases existing risks. This again shows clearly that, under the new Regulation, software is considered a critical part of machine safety.
- Documentation may be provided in digital form
Under current practice and interpretation, the Machinery Directive assumes that the instructions and the EU Declaration of Conformity are supplied with the machine. Under the new Regulation, it is clearly allowed to provide both the instructions and the declaration in digital form, unless the customer requests a paper version.
This change is important because it allows the manufacturer to change and improve the instructions after the products have been placed on the market. This can be critical in situations where risks or patterns of misuse become visible once machines are already in use and should be addressed more clearly in the instructions. The manufacturer can update the digital instructions (while keeping access to the original version), reduce risks related to the machinery, and better inform users.
How to prepare for the new Regulation?
It would be reasonable for manufacturers already during 2026 to start referencing, in their Declarations of Conformity, the Machinery Regulation (EU) 2023/1230 in addition to the Machinery Directive. This assumes that the manufacturer has verified that the products comply with the new Regulation’s requirements. If it turns out that a product does not comply (for example in software, documentation, or safety), the product and the technical file must be updated, and this inevitably takes time.