The European Union’s Machinery Regulation (EU) 2023/1230, which reshapes the EU’s machinery legislation, will become applicable as of 20 January 2027. Replacing the existing Machinery Directive, the new Regulation introduces provisions concerning digital instructions for use, software and control systems affecting machinery safety, substantial modifications, and conformity assessment procedures.

The countdown continues for the implementation of the Machinery Regulation, which updates the rules governing the placing on the market of machinery and related products in the European Union. Adopted in 2023, Regulation (EU) 2023/1230 will generally apply from 20 January 2027. From that date onward, it will replace Machinery Directive 2006/42/EC.

Under the new Regulation, manufacturers will be permitted to provide instructions for use in digital format, provided that certain conditions are met. Digital instructions must be downloadable and printable by the user and capable of being saved on an electronic device. They must also remain accessible online for the expected lifetime of the machinery and for at least 10 years after the machinery is placed on the market. If requested by the user at the time of purchase, printed instructions for use must be provided free of charge within one month.

Software and control systems included in the scope

The Regulation also addresses the digital aspects of machinery safety. It includes provisions requiring control systems to be designed in a way that makes them resilient against malicious third-party intervention that could compromise the safety of the machinery. Safety-related software and control systems are also among the areas covered by the new rules.

The concept of “substantial modification” is defined

The Regulation also introduces a definition of “substantial modification.” Accordingly, a physical or digital modification made to machinery or a related product after it has been placed on the market or put into service, which was not foreseen or planned by the manufacturer, may be considered a substantial modification if it creates a new hazard or increases an existing risk and requires certain additional protective measures.