OTRISK
Regulations · EU Regulation 2023/1230

From 20 January 2027, a machine isn’t safe if it isn’t secure.

The Machinery Regulation replaces the 2006 Machinery Directive. New in the essential requirements: safety-related control systems must withstand corruption, accidental and deliberate. Cybersecurity becomes part of CE conformity for machinery, with no dual period: placed on the market from 20 January 2027 means the new rules.

PUBLISHED
29 Jun 2023
IN FORCE
19 Jul 2023
APPLIES
20 Jan 2027
REPLACES
Directive 2006/42/EC

What it demands

Protection against corruption
Safety survives attack
Safety functions and their control systems protected against corruption, accidental and intentional. Attack included.
Risk assessment, extended
Digital risks in the file
The machinery risk assessment now covers security-relevant digital risks across the lifecycle, documented in the technical file.
Documentation, modernised
Ten years, digital allowed
Digital instructions are permitted; technical documentation is retained for ten years after placing on the market.

Who must care

Machine builders first; importers and distributors with their own duties. Machinery placed on the market before 20 January 2027 stays under the old Directive. No retro-certification.

The OT trap is substantial modification: rebuild a machine deeply enough and you become its manufacturer. Full technical file, under your name.

Where OT comes in

The security part of a safety file is a risk assessment at machine or cell level: scope, threats, targets, measures. That is IEC 62443-3-2 mechanics on a smaller canvas, with 3-3 for the system requirements.

Regulation 2023/1230Essential requirementsSecurity risk assessmentTechnical fileCE marking
Trace it in the map →

How OTRISK helps

Assessment per machine family or cell. In the same workflow as your site assessments, with the same review discipline.
Measures become evidenced requirements. Protection of safety PLCs, access control, update paths: owned, deadlined, reviewed.
Documentation for the technical file. Generated, versioned artifacts instead of a folder of screenshots.

Questions we hear

What about our installed base?

Machines placed on the market before 20 January 2027 remain under the Directive. The Regulation reaches you through new machines and through substantial modifications.

Does machine-CE cover our NIS2 duties?

No. Product law and operator law stack: the machine’s file is the builder’s job; operating it securely is yours.

Are harmonised standards ready?

Harmonisation under the new Regulation is in progress. Until listings settle, document state of the art in the technical file.

SOURCES · FACTS VERIFIED 30 JUL 2026
EUR-Lex · Regulation (EU) 2023/1230 (applies from 20 January 2027)

From standard to signed-off.

Bring one installation in mind. In thirty minutes we show you which parts of OTRISK fit your situation and how the way of working looks. You leave with concrete next steps and pricing.

How the risk assessment runs →