The new EU Machinery Regulation replaces the 2006 Machinery Directive on 20 January 2027. For manufacturers and importers, it brings tighter requirements around cybersecurity, AI-driven safety functions and the technical file. Here is what teams should be doing now.
Regulation (EU) 2023/1230 — the EU Machinery Regulation — was adopted in 2023 and becomes mandatory from 20 January 2027. Until that date manufacturers can continue to place machinery on the EU market under the existing Machinery Directive 2006/42/EC, but every product family launched after the cutover must comply with the new Regulation.
The most material change for most manufacturers is around cybersecurity: machinery with safety functions that depend on network-connected components must demonstrate, in the technical file, that an attacker cannot compromise the safety integrity. In practice this means a documented threat model, evidence of secure-by-default configuration and ongoing patch processes.
AI and autonomous behaviour. Machinery whose safety-relevant behaviour is determined by an AI system is reclassified as high-risk and now requires Notified Body involvement (Annex I). For OEMs adding ML-based features — predictive maintenance, anomaly-based stop functions, vision-guided robotics — this is a meaningful change in conformity assessment route.
Substantial modifications. The Regulation introduces a new concept: when a third party significantly modifies machinery already on the market, that party becomes responsible for re-conformity. This affects integrators, retrofit shops and end-users who alter equipment.
Digital instructions. Manufacturers can now provide instructions for use in digital format, with paper available on request. This sounds minor, but the conditions (versioning, accessibility, language coverage) are precise and worth getting right early.
What we recommend doing now. Audit your existing technical files against the new Annex III — the structure has changed. Map each product family to a target conformity assessment route under the new rules. For products that may shift into Annex I (high-risk), engage a Notified Body before Q3 2026 — capacity will tighten as the deadline approaches.
Boem's CE marking team is already running gap audits against the new Regulation for clients across industrial machinery, robotics and lifts. Contact us if you would like a structured review of your current machinery portfolio.
