Pilz helps you to implement changed requirements - The new Machinery Regulation has been published!

Today, on 29.06.2023, the “Machinery regulation (EU) 2023/1230” (below: Machinery Regulation) was published in the Official Journal of the European Union. Machine manufacturers and operators have 42 months in which to meet the new requirements on plant and machinery. The regulation provides more precise specifications for how to handle substantial modifications on a machine, as well as machines subject to inspection. What’s more, it also takes into account the growing importance of Digitisation and Industrial Security. Experts from Pilz help companies to implement the new features successfully with a comprehensive services package.

The Machinery Directive 2006/42/EC has always had special significance in terms of the functional safety of machinery. That’s because it is concerned with the standardisation of fundamental and mandatory European machinery safety requirements. Now republished as the Machinery Regulation, the specifications have been upgraded to the state of the art.

Mandatory Cybersecurity
The new regulation continues to cover machinery and related products, but safety components now also include software. It provides greater clarity as to when there is a substantial modification to existing plant and machinery, and therefore a new CE conformity assessment must be conducted. If a substantial modification has taken place, the user becomes the manufacturer – with all the obligations that entails. The new Machinery Regulation lists six machine categories under “potentially high risk machinery”  –  including with regard to artificial intelligence – where machine manufacturers can no longer self-declare compliance in conjunction with a harmonised standard, as previously. In future, a notified body must be involved.
New: In contrast to the Machinery Directive, rather than looking purely at safety, the Machinery Regulation also includes cybersecurity as a protection goal in the “Essential health and safety requirements (EHSR)”, under “Protection against corruption”.  Cybersecurity threats must not be allowed to compromise the machine’s safety functions. For some manufacturers, this entails a revision of their existing safety and security concepts.

State of the art
Some things are also simpler: Digital operating manuals and digital EU declarations of conformity are possible under certain framework conditions. Hardcopy must only be supplied at the customer’s request.
“To summarise, the new regulation takes into account the technological changes of the last few years”, says Klaus Dürr, Vice President Standards Group at Pilz. “With a defined transition period of 42 months, the standards committees now have a lot of work ahead of them. So it remains exciting whether the relevant standards will be available as harmonised standards by the time the Machinery Regulation becomes mandatory."

Machine manufacturers and operators are not alone
Pilz has supported machine manufacturers for years with a comprehensive package of machinery safety services, from safety analysis to validation and CE marking. Experts from Pilz advise customers in the event of a substantial modification to plant and machinery in accordance with the requirements of the Machinery Regulation. Pilz also has the new normative security requirements in its sights – because Industrial Security ensures the integrity of safety at the machine: which is why the company has added relevant training in Industrial Security to its services package.

More information about the new Machinery Regulation is available here