In the context of the functional safety of machinery, the Machinery Directive 2006/42/EC has always been of particular importance, as it deals with the standardization of basic and mandatory European safety requirements for machinery. Now republished as the Machinery Directive, the requirements have been brought up to date with the current state of the art.

The Machinery Regulation continues to cover machinery and associated products, but extends the safety components to include software. It provides greater clarity as to when a significant change has been made to existing machinery and systems and therefore a new CE conformity assessment must be carried out. This means that users become manufacturers as a result of a significant change - with all the associated obligations. For example, the new Machinery Regulation lists six categories of machinery under "potentially high risk machinery" - including in relation to artificial intelligence - for which machine manufacturers can no longer declare conformity themselves in conjunction with a harmonized standard, as was previously the case. In future, a notified body must be consulted for this.

In contrast to the Machinery Directive, the Machinery Regulation includes the protection objective of cybersecurity in the "essential health and safety requirements (EHSR)" as "protection against corruption" in addition to the pure consideration of safety. This means that cybersecurity threats must not impair the safety functions of the machine. For some manufacturers, this entails a revision of their previous safety and security concepts.

There are also simplifications in the Machinery Directive: digital operating instructions and digital EU declarations of conformity are possible under certain conditions. The paper version only has to be supplied at the customer's request.

"In summary, the new regulation takes into account the technological changes of recent years," explains Klaus Dürr, Vice President Standards Group at Pilz. "With the specified 'transition period' of 42 months, the standards committees now have a lot of work ahead of them. It will therefore be interesting to see whether the relevant standards will be available as harmonized standards by the time the Machinery Regulation becomes mandatory."