Industries
Machinery under pressure:
Three EU regulations. One window. Act now.
CRA · EU AI Act · Machinery Regulation 2023/1230 · GDPR — what every OEM must know from 2026
The numbers
Fines and deadlines at a glance
€35M
max. EU AI Act fine
or 7% of annual turnover
€15M
max. CRA fine
or 2.5% of annual turnover
20 Jan 2027
Machinery Regulation fully applicable
New CE logic for AI machinery
What changed?
Old directive vs new regulation
| Machinery Directive 2006/42/EC (OLD) | Machinery Regulation 2023/1230 (NEW) |
|---|---|
| Software not a separate regulatory object | Software explicitly part of the machine |
| AI/ML: no specific requirements | AI in safety functions = high-risk component |
| Software updates after CE unregulated | Substantial change via update → new CE procedure |
| Directive → national transposition required | Regulation → directly applicable in all EU states |
Regulatory layers
Four regulations affecting machinery OEMs
Cyber Resilience Act
Every firmware image, every microcontroller = regulated product. Notification duty from 11 September 2026.
Learn more →EU AI Act
OEMs with AI-enabled machinery are providers — 12 obligations and fines up to €35M.
Learn more →Machinery Regulation 2023/1230
Not an update — a system change. Every OTA update can trigger a new CE procedure.
Learn more →GDPR & employment law
Vision systems and cobot sensors capture personal data. In Austria: ArbVG blocking condition.
Learn more →What we deliver
From gap analysis to implementation
Technical implementation
Firmware hardening, security by design, OTA update architecture, SBOM creation
Regulatory gap analysis
Regulatory Readiness Check in one day — CRA, EU AI Act, Machinery Regulation 2023/1230
Workshops
Three workshop formats for OEMs and compliance teams — from half-day to full day
Three regulations. Three deadlines. One partner.
Solvetronix supports machinery builders and OEMs from gap analysis through technical implementation.
Request a free initial assessmentQuestions about EU compliance?
We review your products and roadmap in a free initial assessment — CRA, EU AI Act, and Machinery Regulation.
Request a free initial assessment