Machinery Regulation 2027: What Machinery Manufacturers Need to Know Now
As of June 2026
Effective January 20, 2027, the new Machinery Regulation (MVO) will replace the decades-old Machinery Directive 2006/42/EC—immediately and uniformly across Europe. It introduces significant substantive changes: cybersecurity becomes a manufacturer’s obligation, AI systems are explicitly covered, and digital operating instructions are now regulated. Those who fail to comply risk losing their CE marking.
What is the new Machinery Regulation?
The Machinery Regulation (EU) 2023/1230 is the new European regulatory framework for machinery manufacturers, importers, distributors, and operators. It replaces the Machinery Directive 2006/42/EC without a transition period—as of January 20, 2027, only the Machinery Regulation will apply.
| Characteristic | Details |
| Cutoff Date | January 20, 2027 |
| Replaces | Machinery Directive 2006/42/EC |
| Applies to | Machine manufacturers, importers, dealers, and operators in the event of a significant change |
| Period of Coexistence | None—as of the effective date, only the MVO applies |
What specific changes are being made to the Machinery Regulation?
Cybersecurity Is Becoming a Manufacturer’s Responsibility
Without an industrial security strategy, CE marking will no longer be permitted starting in 2027. Machines with digital interfaces or network connectivity must be demonstrably protected against unauthorized access and tampering.
Tip: Organizations that consistently implement the requirements of the Cyber Resilience Act (CRA) will, in many cases, already be in compliance with the cybersecurity requirements of the GDPR.
AI and autonomous systems are expressly covered
Self-learning or AI-powered machine components are subject to clear requirements. Anyone who installs such systems must document their behavior and ensure it can be controlled.
Digital User Manuals – Permitted, but Regulated
In the future, instruction manuals may be provided in digital form—subject to new requirements regarding availability, accessibility, and format. Manufacturers must ensure that the digital instruction manual remains available for at least 10 years after delivery.
Significant Change—Redefined
For the first time, the MVO clearly defines when a modification to a machine is considered “substantial.” Anyone who makes a substantial modification to a machine assumes all manufacturer obligations—even if the changes are purely software-based—as soon as they affect safety or render the original risk assessment invalid.
Stricter Conformity Assessment for High-Risk Machinery
For certain categories of machinery, it is mandatory to involve external testing agencies—a self-declaration is no longer sufficient in such cases.
Who is covered by the Machinery Regulation?
- Machinery Manufacturers (OEMs) – regardless of where their headquarters are located
- Special-purpose machine builders and system integrators
- Importers of machinery from third countries
- Distributors who make machinery available on the EU market
- Operators who make significant modifications to machines—thereby becoming manufacturers
What You Should Do Now
- Impact Analysis: Which of your machines are subject to the MVO?
- Gap Analysis: How do your current processes differ from the new requirements?
- Security Risk Assessment: Do you have an industrial security plan for your machines?
- Review Your Documentation: Are Your Technical Documents and Operating Instructions in Compliance with MVO?
- Clarify Your AI Requirements: Do You Use AI Components in Your Machines?
- Preparing Digital User Manuals: How Will You Make Them Available and Keep Them Accessible for 10 Years?
We help you ensure CSR compliance
ROTH Steuerungstechnik GmbH supports you on your path to compliance:
- Impact Analysis and Gap Analysis
- Risk Assessment in Accordance with the GDPR, Including an Industrial Security Analysis
- Cybersecurity Risk Assessment (TARA) in accordance with IEC 62443
- Preparation of technical documentation and the EU Declaration of Conformity
- Consulting on Digital User Manuals and Their Management
Please contact us for an initial assessment of whether and how CSR affects your company.
Note: Manufacturers of machines with digital interfaces are also subject to the Cyber Resilience Act (CRA) 2027. Read our article on the CRA to learn how to best combine both sets of requirements and save resources.
As of June 2026. All information is based on the Machinery Regulation (EU) 2023/1230.
