Differences between the Machinery Regulation and the Machinery Directive

Although many of the requirements in the Machinery Regulation are the same as those in the Machinery Directive, there are some significant differences intended to address today’s conditions and requirements.

Digital Manuals

Manufacturers now have greater opportunities to provide their documentation digitally. For machinery intended exclusively for professional users, the entire instruction manual may be provided in digital format.

The digital instruction manual must be:

• Easy to find: The manufacturer must clearly state how the user can access the digital instruction manual.
• Easy to print: It must be easy for the user to download and print the instruction manual in paper format.
• Available long-term: The instruction manual must remain available online throughout the expected lifetime of the machinery and for at least 10 years after the product has been placed on the market.

Some requirements for paper-based instruction manuals remain:

• Free paper copy: At the time of purchase, the user may request the instruction manual in paper format. The manufacturer must then provide it free of charge within one month.
• Safety information on paper for consumers: For machinery that may be used by non-professional users, the basic safety information required for safe installation and use must always be provided in paper format.

Specific Documentation for AI

For machinery that uses artificial intelligence, machine learning, or self-developing logic, the Machinery Regulation introduces three key requirements concerning data logging and traceability.

Safety-Related Decision-Making Process

The decision-making process used by an AI-driven control system to make safety-related decisions must be logged and stored for at least one year.

Traceability Log

The control system must have an activated traceability log that retains information for five years after uploading.

The log must cover data generated in connection with interventions and record all versions of safety-related software uploaded after the machinery has been placed on the market or put into service.

Logging of Authorized and Unauthorized Interventions

As part of the requirements for cyber security and protection against tampering, the machinery must collect evidence of both authorized and unauthorized interventions or modifications to the software.