A machine thatlearns is amachine thatwas never tested.
- Applies from
- 20 January 2027
- Replaces
- Directive 2006/42/EC
- Form
- Regulation, directly applicable
- New ground
- Autonomy, software, cyber
A Directive became a Regulation, and the gap between twenty-seven laws closed.
What it requires
AI in a safety function means a notified body, not self-declaration
The high-risk list gained two categories written for machine learning: safety components with fully or partially self-evolving behaviour, and machinery with embedded AI systems performing safety functions. Part A machinery cannot be self-certified. The route to market runs through a third party.
Software is a safety component
The essential health and safety requirements were extended to treat safety-related software as part of the machine rather than as something loaded onto it. A software update is a change to a safety component and is governed as one.
Protection against corruption
A machine that communicates, wirelessly or otherwise, must not be made hazardous by that communication, and its safety software must be protected against unintended and deliberate modification. Cybersecurity stopped being an IT concern and became an essential safety requirement.
Every intervention in safety software is logged, and kept five years
The control system must record evidence of every intervention in the safety software, conscious or otherwise, and the logs must remain available for at least five years after modified software is uploaded. For the first time, what a machine's safety logic was on the day of an accident is a documented fact rather than a reconstruction.
Conformity is assessed on a machine that has not finished changing
Conformity assessment describes a machine at a moment. A system whose behaviour evolves is not the machine that was assessed, and the Regulation is the first to say so out loud. What follows from that — who answers for behaviour nobody specified — is the question the next decade of product liability turns on.