EU Machinery Regulation (2023/1230)

It applies to manufacturers, importers, and authorized representatives who place machinery, partly completed machinery, interchangeable equipment, or certain safety components on the market in the EU – ranging from machinery and plant engineering to automation technology and manufacturers of robotics and safety components. Suppliers are also affected, as they must provide the relevant proof of conformity and technical documentation as part of the supply chain.

• Essential health and safety requirements: still at the core of the regulation, supplemented by new risk categories

• Digital operating instructions: permitted for the first time as an equivalent alternative to the paper version

• Cybersecurity: protection against tampering with safety-related software in networked and software-controlled machines

• AI safety functions: additional conformity assessment for machines with self-adaptive behavior in safety-related functions

• Expanded list of high-risk machines: revised and expanded list of machines requiring mandatory involvement of a notified body

• Traceability: complete documentation throughout the entire product lifecycle as the basis for the declaration of conformity

The formal difference lies in the legal nature of the regulations: As a regulation, the new set of rules applies directly in all EU member states, whereas the previous directive first had to be transposed into national law – in Germany, for example, the Product Safety Act. In terms of content, the basic structure – including risk assessment, essential safety requirements, and conformity assessment procedures – remains unchanged, but has been expanded to include digital instruction manuals, mandatory cybersecurity requirements, and regulations for AI-supported safety functions – topics that were not yet technically relevant in 2006.

Without a CE marking that complies with the new regulation, a machine may no longer be placed on the market in the EU as of the mandatory effective date. For machines already on the market, there is a risk of sales bans, recalls, and fines imposed by market surveillance authorities; particularly for networked machines, cybersecurity risks are also becoming a key focus of regulatory inspections. Since the transition period ends in January 2027, manufacturers are already facing time pressure to update their technical documentation and operator’s manuals.

• EN ISO 12100 – risk assessment and risk reduction in mechanical engineering

• ISO 9001 – basic quality management standard

• EN 1090 – execution of steel and aluminum structural works

• EN 10204 – material certificates and material verification