The requirements you need to be aware of regarding stricter rules for machinery manufacturers

Why is the Machinery Regulation being introduced?

– The background to this is new technology and the new risks that it poses. The Directive did not address these risks, but the Regulation does. The Regulation also means that legal requirements will be harmonised and become the same across all EU Member States. Previously, countries might have had additional national rules or exemptions, but when the Regulation comes into force, the same rules will apply throughout the EU. It should be seen as a tool and guide for placing safe products on the market, so that neither property nor people come to harm, explains Charlotta Uddh, project manager for machinery safety at RISE.

Who is covered by the regulation?

Anyone who designs or sells machinery within the EU's single market — the area of free trade comprising the EU, Norway, Iceland, Liechtenstein and, to a certain extent, Switzerland — is covered by the regulation. This applies to start-ups developing autonomous forklift trucks, as well as multinational companies selling traditional wheel loaders. Many of the Regulation's requirements are the same as those in the Directive, but new requirements have been added for machinery exhibiting fully or partially self-developing behaviour that uses machine learning methods. In other words, this covers machinery with artificial intelligence and an internet connection.

– The changes also concern protection against tampering, which is a matter of cybersecurity, says Charlotta Uddh.

What do machine manufacturers need to do to comply with the new requirements?

– In most cases, the simplest approach will be to use a harmonised standard. The problem is that the regulation has progressed further than the standards committees have. Over 1,000 harmonised standards were linked to the Machinery Directive, and not all of them will be updated in time for 2027, says Uddh. 

– Our general recommendation is to use the latest applicable standard for your product area to incorporate the latest technology and receive guidance and support during the design process. If the latest version has not yet been harmonised, the manufacturer cannot automatically demonstrate compliance with the Machinery Directive requirements. In such cases, it is important to document why this particular version of the standard has been chosen and how compliance with the legislative requirements can be ensured.

In order to be sold on the EU market, a machine must bear the CE mark. This mark indicates that the machine complies with all relevant EU requirements relating to safety, health and the environment. Once the Machinery Regulation comes into effect, it will incorporate safety requirements relating to AI, connectivity and cybersecurity into the CE mark.

– The CE mark acts as a passport for the product, enabling it to circulate freely within the EU.

What does the machine manufacturer need to do to comply with the new requirements?  

– In most cases, it is easiest to use a harmonised standard. The problem is that the regulation has progressed further than the standards committees have. Over 1,000 harmonised standards were linked to the Machinery Directive, and not all of them will be updated in time for 2027, says Charlotta Uddh, continuing:  

– Our general recommendation is to use the latest version of the standard applicable to your product area, in order to take account of new technology and to receive assistance and support during the design process. If the latest version has not yet been harmonised, this means that the manufacturer cannot automatically demonstrate compliance with the requirements of the Machinery Directive. In such cases, it is important to document why this particular version of the standard has been chosen and how compliance with the legal requirements can nevertheless be ensured. 

For a machine to be sold on the EU market, it must bear the CE mark. The CE mark is your own declaration that the machine complies with all relevant EU requirements relating to safety, health and the environment. When the Machinery Regulation replaces the Machinery Directive, the safety requirements relating to AI, connectivity and cybersecurity will be incorporated into the CE mark. 

– The CE mark is like a passport for the product and allows it to move freely within the EU.  

What do you think the biggest challenge will be for machine manufacturers?

– It’s a new development, and things are changing rapidly. The authorities are taking a more active role and looking into these matters. If the Swedish Work Environment Authority comes to carry out an inspection, you need to be able to produce technical documentation proving that your machine meets all the requirements, says Charlotta Uddh, continuing:

– If the visit is due to a workplace accident involving a specific machine, the machine may need to be withdrawn from the market. However, even incomplete documentation can have serious consequences, so my advice is to get your paperwork in order well in advance.