New EU Machinery Regulation - What You Need to Know

On 29 June 2023, the new EU Machinery Regulation (EU) 2023/1230, which will replace the current Machinery Directive (2006/42/EC), was published in the EU Official Journal. Notably, the UK government has indefinitely extended CE marking for machinery beyond 2024. The new Machinery Regulation will be applicable from 20 January 2027, when CE-marked products in the UK must also comply with EU regulations. At this time, we have not heard if UK regulations will be amended so that UKCA requirements will align with the EU. It is assumed that any UKNI+CE marking must meet the new EU Regulation.

This new regulation brings stricter safety provisions that are a legal requirement for machinery manufacturers and other economic operators, offering more legal certainty for end-users by establishing binding requirements for the design, construction, and placing into operation of machinery and related products.

Terminology changes aim to reduce confusion caused by the use of the generic term ‘machinery’. Instead, the new regulation refers to "machinery and related products" and differentiates "machine" from "related products". This clarity should simplify conformity assessments.

The rise of IIoT and Industry 4.0 has introduced smarter machinery and highly connected factories coming online, but the old directive was not up to date to tackle the new safety and security challenges within these environments. The new regulation now covers areas such as cybersecurity of safety control systems and of software related to the conformity assessment of the machinery; use of artificial intelligence (AI) in safety functions; autonomous and remote-controlled mobile machinery; and collaborative robots (“cobots”).

For example, under the topic of cybersecurity 1.1.9 of Annex III outlines requirements for the protection against interference to prevent dangerous situations arising from the remote linking of a device. The regulation also distinguishes between unintentional changes (employees without malicious intent) and intentional corruption (hacking/social engineering). This aligns machinery regulations with other EU laws like the Cyber Resilience Act and update to the RED concerning cybersecurity.

The Regulation also clarifies "substantial modification" of machinery, considering those who modify machinery significantly as manufacturers. They must therefore fulfil all obligations associated with this role, in particular they must carry out a new conformity assessment. However, only the modification's conformity needs assessment if it increases health and safety risks.

Another major change is the mandatory Notified Body conformity assessment for at least six high-risk product categories, from vehicle servicing lifts to safety components with fully or partially self-evolving behaviour using machine learning. High-risk machinery in Annex 1-B maintains the same conformity option as Annex IV machinery within the Machinery Directive.

The new regulation's scope is broader, covering the entire supply chain and imposing concrete obligations for all market participants, including distributors of new and used machinery.

Additionally, it reduces administrative workload for machinery manufacturers as instruction manuals no longer need to be printed as long as they are available to download and print. If requested, printed operating instructions must be supplied within a month.

Although the Regulation is now in force throughout all EU member states, there's a three-year transition period, with mandatory compliance starting 20 January 2027. Given the extensive requirements, manufacturers should start adapting to these new rules as soon as possible. We recommend that you start considering the new requirements well in advance of the deadline, as it can take some time to prepare the required documentation and certifications.

How we can support your machinery safety needs

Partner with TÜV SÜD to ensure your products meet the new EU Machinery Regulation. Gain expert guidance in quality, safety, and compliance to successfully launch your products and access new markets. Find out more about our machinery safety services.

You may also be interested in our range of machinery safety training courses.