The old Machinery Directive (2006/42/EC) has governed machine safety and compliance for over two decades, but its time is up. In its place comes the Machinery Regulation (EU) 2023/1230, bringing changes that every OEM, automation specialist, and maintenance professional in the EU—or selling into the EU—must understand.

And this time, there are no opt-outs, no delays, no loopholes: unlike a directive, a regulation applies directly and uniformly across all EU Member States. Translation: you either comply—or you’re out.

ABB’s recent webinar, led by standardisation and certification specialist Anette Wester-Odbratt and market developer Andree Hoffmann, served up a timely breakdown of what’s coming. Here’s what Mainworld readers need to know—and do.

The regulation’s scope is broader and tougher than ever. It now formally includes “quasi-machinery”, digital safety components (including software), partly completed machinery, and introduces new categories like related products (e.g., sensors, slings, chains).

One of the most significant game-changers is mandatory third-party certification for six types of machinery listed in Annex I, especially those with self-evolving behavior or AI-driven functions. For the first time, cyber risks and software integrity are part of the safety equation.

And this is not theoretical. From 2027 onwards, any new machinery placed on the EU market must meet these standards.

Practically it means, if your machine isn’t compliant, it isn’t sellable.

Even the documentation game has changed. Manufacturers can now provide digital-only instructions, but customers can still request printed manuals at the time of purchase. CE markings also get a digital upgrade—products certified by a notified body must now include that body’s ID number next to the CE mark. QR codes are encouraged to streamline access to declarations of conformity, instructions, and technical files.

The regulation also raises the bar for machine software updates, which now require detailed logging of safety-relevant changes—retained for five years and accessible by authorities. That means more traceability and less room for error—or excuses—when accidents happen.

Then there’s "substantial modification", a term now legally defined. If a machine is modified post-market in a way not planned by the original manufacturer—and that change introduces new hazards—it must be recertified from scratch. Think of it as a forced reset button on your compliance obligations.

One standout element in the new regulation is its emphasis on cybersecurity and communication integrity. Machines must now withstand not only physical stress but also intentional digital interference—in line with the EU’s Cybersecurity Act. A new standard, EN 50742, is in development to guide manufacturers through these challenges.

Another critical evolution: human-machine collaboration is addressed with stricter rules. From ergonomic design to minimizing psychological stress when working near collaborative robots, the regulation is catching up with how automation functions today.
As for harmonized standards, over 850 are in the process of being revised or transferred to align with the new regulation. For machines not covered by an updated harmonized standard, a full notified body certification will be required.

To sum it up, the EU Machinery Regulation (2023/1230) marks a shift in how machines are certified, documented, and maintained across the continent. It’s not a bureaucratic reshuffle—it’s a digital, legal, and safety revolution.

ABB’s experts made one thing clear: 2027 is not far away. If you're waiting until then to prepare, you’ve already waited too long. This isn’t just about ticking a regulatory box. It’s about staying competitive in an industrial world increasingly shaped by digitalization, AI, and traceable accountability. Companies that prepare now won’t just be compliant—they’ll be ahead of the curve.

Text: Mia Heiskanen   Photos: ABB