On June 29, 2023, the Machinery regulation (EU) 2023/1230 (hereinafter referred to as: Machinery Regulation) was published in the Official Journal of the EU. Machine manufacturers and operators have 42 months to meet the new requirements for plants and machines. The regulation provides more precise specifications on how to deal with major modifications on machines and machines that need to be inspected. More importantly, it also takes into account the growing importance of digitization and industrial information security. Piermagnetic’s experts will help the company successfully implement new features through a comprehensive range of services.

Machinery Directive 2006/42/EC (Machinery Directive) has always been of special significance in the area of functional safety of machinery. This is because it involves the standardisation of basic and mandatory machinery safety requirements in Europe. Now reissued as “Machinery Regulation”, its specifications have been upgraded to the latest level.

Mandatory network security

The new regulations continue to cover machinery and related products, but safety components now also include software. It provides greater clarity on when substantial modifications have been made to existing plants and machinery, so that a new CE compliance assessment must be carried out.

MVI46-MCM

If a substantial modification occurs, the user becomes the manufacturer and assumes all obligations. The new Machinery Regulations list six machine categories (including artificial intelligence) under “potentially high-risk machinery,” and machine manufacturers can no longer self-claim compliance with harmonized standards, as they did before. In future, a notified body must be involved.

Update: In contrast to the Machinery Directive, the Machinery Regulation does not focus solely on safety issues, but rather addresses cybersecurity as a protection objective under “prevention of corruption” in the Basic Health and Safety Requirements (EHSR) : cybersecurity threats must not be allowed to compromise the safety functions of machines. For some manufacturers, this means revising their existing safety concepts.

“All in all, the new regulations take into account the technological changes of the past few years,” said Klaus Durr, Vice President of Standards at Peelmagneto. “The standards committees now have a lot of work to do during the required 42-month transition period. It will be interesting to see whether the relevant standards will emerge as harmonised standards when the EU Machinery Regulation comes into force.”

Pilmagnetic has been providing machine manufacturers with a comprehensive portfolio of mechanical safety services for many years, from safety analysis to validation and CE marking. Our experts advise customers when making major modifications to plants and machinery in accordance with the requirements of the Machinery Regulations. The company is also concerned about the new regulatory safety requirements, as Industrial information security ensures the integrity of machine safety: this is why the company has added training related to industrial information security to its services.