107 days to go: what the Machinery Regulation means for self-learning safety functions

The EU Machinery Regulation, (EU) 2023/1230, replaces the Machinery Directive and becomes mandatory on 20 January 2027 (Pilz). For most machines, little changes. For machines whose safety depends on machine learning, a lot does.

The two new high-risk categories

Annex I, Part A of the regulation lists machinery that must always go through a notified body. Two entries are new (EUR-Lex):

• “Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions.”
• “Machinery that has embedded systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions that have not been placed independently on the market, in respect only of those systems.”

For these, the manufacturer cannot self-certify, even if it followed harmonised standards. A third party must assess conformity.

What does not count

The regulation says the third-party rule applies only to systems with self-evolving behaviour using machine learning. Software “programmed only to execute certain automated functions” is not caught. A vision system that flags weld defects for a person to check is not a safety function. A learning system that decides when a robot cell is safe to enter is.

On the floor

• Machine builders should map their range against Annex I now. Demand for notified body assessments is expected to build as January approaches.
• Plant operators who retrain or modify a machine’s learning behaviour beyond what the manufacturer foresaw may become the manufacturer in law, with the conformity duties that brings.
• Safety engineers need the learning phase documented: the regulation requires that changes from learning must not create a hazardous situation.

We will track notified body capacity and early certifications in Germany, Austria and Switzerland as the date approaches. Switzerland is outside the EU, but Swiss machine builders selling into the EU must meet the regulation.