Contact person
Charlotta Uddh
Projektledare
Contact Charlotta
The requirements you need to be aware of regarding stricter rules for machinery manufacturers
Do you manufacture machinery? If so, EU regulations will probably be familiar to you. The EU has had common requirements for machinery in place for over 30 years to improve safety, facilitate free trade and reduce risks to workers. However, stricter requirements will apply from 2027 when the Machinery Regulation replaces the Machinery Directive.
– The background is new technology and, consequently, new risks. The directive did not address these issues, but the regulation does. The Machinery Regulation also means that legal requirements will be harmonised and will be the same throughout the EU. Previously, a country 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 machine safety at RISE.
Who does the Regulation cover?
The regulation covers anyone who manufactures or sells machinery within the EU’s so-called single market, which comprises the common rules, customs duties and charges that apply to EU countries, Norway, Iceland, Liechtenstein and, to some extent, Switzerland. This applies to both start-up companies developing autonomous forklifts and multinational corporations selling traditional wheel loaders. While many of the requirements in the Regulation are the same as those in the Directive, new requirements have been added for machines with fully or partially self-developing behaviour that use machine learning methods. In other words, machines with artificial intelligence and an internet connection.
– The changes also concern protection against tampering, which is a cybersecurity issue, says Charlotta Uddh.
What steps must the machine manufacturer take to comply with the new requirements?
– In most cases, it is easiest to use a harmonised standard. The problem is that the regulations have progressed further than the standards committees. 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:
How can we support?
Would you like some guidance on how the new Machinery Directive affects you as a machinery manufacturer? If so, please contact us by filling in the form.
– 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.
The CE mark acts as a passport for the product, enabling it to circulate 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.
Five steps to achieving regulatory compliance by 2027
- Conduct a requirements analysis to determine whether you are covered by the Machinery Directive. Often, several sets of regulations must be complied with simultaneously. A requirements analysis also involves identifying which standards can be used as a basis for design.
- The next step is to carry out a risk assessment and draw up an action plan to minimise the risks.
- Set clear requirements when making purchases. Purchase products that are already CE-marked and build the machine using high-quality components to make the process easier further down the line.
- Arrange for an accredited body to test the machine in accordance with the standards identified in Step 1.
- Don't forget the mandatory user manual for the machine! The regulations allow it to be provided digitally.
About the Machinery Directive
The Machinery Regulation, which was adopted in June 2023, will come into force in January 2027. It replaces the previous Machinery Directive, which was transposed into Swedish law. From 2027 onwards, the same rules will apply throughout the EU. The main changes are:
- There will be stricter safety requirements for machinery and work equipment in order to address the new technical risks associated with software, artificial intelligence (AI) and connected systems.
- In order to reduce paper consumption and administrative work, user manuals in digital format will be permitted.
- Responsibilities and roles of manufacturers, importers and distributors clarified.
- There should be stricter rules for the assessment and control of high-risk machinery, particularly that involving AI.
The Swedish Work Environment Authority is responsible for market surveillance in Sweden. It may take the following measures against non-compliant machinery:
- Prohibition on sale: Machinery that does not meet the required standards must not be sold or put into service on the EU market.
- Recall: Machinery may need to be withdrawn from the market.
- Administrative fines: Administrative fines may be imposed for the use of non-CE-marked machinery, for example.
- Prohibitions and injunctions: enforcement measures to remedy deficiencies.
