The new Machine Regulation: Old wine in new bottles?

From January 20, 2027, the European Machinery Regulation (2023/1230) will replace the current Machinery Directive. What does this mean for machine builders? According to safety consultant Martijn Drost, the impact is limited: "There are some tightening measures, but the core remains familiar and clear."

Martijn Drost knows the mechanical engineering industry inside and out. Through his firm, Drost Safety Consultancy, he supports companies with safety, CE marking, and compliance. He also advises manufacturers on the introduction of the new Machinery Regulation. This will replace the current 2006 Machinery Directive in 2027 and is intended to ensure greater uniformity within Europe.

"The European Union wants to create a level playing field with the new regulation," says Drost. "A directive must first be transposed into national law, which creates minor differences between European countries. The regulation will apply directly to all member states. This will make the rules clearer and trade within Europe fairer."

Technological developments

Besides creating a level playing field, technological developments are a key reason for the new regulation. Digitalization, AI, and robotization bring new risks, and legislation must be prepared for them. That's why, among other things, cybersecurity requirements have been added. "In the IT world, this is self-evident, but not in mechanical engineering," says Drost. "Many operating systems are never updated. As long as a machine runs standalone, it's fine. But as soon as you connect the machine to a network, the same risks apply as in IT."

New rules also apply to the use of artificial intelligence. When a machine uses AI on safety-critical components, it must be assessed by a notified body Mandatory. Drost illustrates this with an example: "Consider a robot operating independently in an open space. If it were to circumvent security measures using AI, you must be absolutely certain that this is done safely. This provides an additional safeguard for situations where humans and machines work closely together."

Unfinished machines: debate continues

A hot topic in the industry is the category of partly completed machinery (2B). Some manufacturers deliberately label machines as partly completed to circumvent safety regulations. Drost explains: “Sometimes manufacturers essentially cut the plug and say: 'This is an partly completed machine, you have to connect it yourself, so we don't have to deliver it according to the Machinery Directive.' The new regulation has drawn the line a little more clearly, but the definition itself has hardly changed. If a machine can actually function independently, it simply falls under the stricter '2A' regulations. It would have been helpful if the dividing line had been defined even more clearly to avoid disputes.”

One discussion that has been resolved concerns the roles of importers and distributors. Drost explains: “The roles of the importer and distributor are now explicitly defined, which allows for oversight of imports from countries like China in particular. Some parties try to source and sell junk from abroad, and until now, regulators have had little control over this. They could only address the end user, while they really wanted to target the importer. The new rules finally provide a legal basis for this and thus help better protect the market.”

A more readable document

Despite the new articles and tightened definitions, Drost emphasizes nuance. “There's a lot of fear surrounding the new regulation. People think everything will change completely, but that's not the case. Procedures and references have shifted, but the document itself has become more readable. Moreover, the market is better protected.”

 Drost advises manufacturers to read the information well in advance, as there is no transition period for manufacturers. "The directive will expire on January 20, 2027, and the regulation will apply immediately," he warns. Drost therefore recommends starting early. "Just start reading, and you'll see it's actually not that bad. Take a look at Articles 10 and 11, and the general principles in Annex III. You'll see that the texts are clearer and improved. The regulation primarily provides clarity and ensures that everyone works under the same rules."

Want to learn more about the practical impact of the new European Machinery Regulation? Martijn Drost will be a speaker at the Machinebouw event 2025 on Tuesday, December 2nd at Congrescentrum 1931. During his plenary presentation, he will explain the key changes and discuss concrete steps manufacturers can take now regarding design, documentation, and compliance.