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
Connected products with digital elements may fall under the CRA. Scope, reporting and product obligations must be assessed per product.
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. Certain OTA updates can trigger a new CE procedure depending on the safety function.
Learn more →NIS2 & NISG Austria
For OT, IoT, and industrial IT in Austria: scope assessment, management duties, and technical implementation.
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 Regulatory Readiness CheckQuestions about EU compliance?
We assess your regulatory and technical baseline for CRA, EU AI Act and Machinery Regulation and outline a reasoned next step.
Request a Regulatory Readiness Check