Comparing the technical requirements in mechanical engineering and automation technology today with those from 2009, it becomes clear that an update of the previous directive was necessary. Digitalization, connectivity, and new areas such as industrial security and artificial intelligence (AI) are increasingly shaping modern production. To address these developments, the legal requirements have been adapted to the current state of technology.

The regulation was officially published on July 29, 2023, and will fully come into force on January 20, 2027. Until then, the current Machinery Directive 2006/42/EC remains applicable.

The Machinery Regulation applies to all companies that manufacture, place on the market or put certain machine products into operation. This includes the following products:

• Machinery
• Interchangeable equipment
• Safety components
• Lifting accessories
• Chains, ropes, and webbings
• Removable mechanical transmission devices
• Partly completed machinery

The key changes include, among others:

• Higher requirements for cybersecurity and protection against unauthorized access to hardware and software.
• Explicit regulations for machine learning / AI-based systems in safety-related functions.
• Possibility and requirements for digital provision of operating instructions and electronic declarations of conformity.
• New definitions and stricter rules for substantial modifications of existing machines.
• Expanded reporting and documentation obligations for manufacturers, importers, and distributors.

No, it only applies to machinery placed on the market starting January 20, 2027. You can continue to use existing machinery that conforms to the old Machinery Directive.

But if you make “substantial modifications” to an existing machine after January 20, 2027, the new Machinery Regulation will have to be applied.

Yes – if a modification is classified as a “substantial modification”, the machine must be treated as a new machine and undergo a new conformity assessment. This involves updated documentation, risk assessments, and, if necessary, retrofitting or adjustments to meet the new requirements of the regulation.

No. All machines that are placed on the market before the binding deadline of January 20, 2027 should receive the EC conformity assessment according to the currently valid Machinery Directive 2006/42/EC. The new Machinery Regulation only applies to machines that will be placed on the market from January 20, 2027.

The Machinery Directive 2006/42/EC stipulates the requirements for the design and placing on the market of machines in the European Economic Area (EEA). The task and objectives are fundamentally the same as those of the new Machinery Regulation.

The difference between a European directive and a regulation is that with an EU regulation there is no need for the member states to implement it into national law: regulations have a “reaching effect” for all member states and are therefore directly legally binding. This reduces the administrative burden because actors do not have to deal with potentially different national implementations.

It is only a slight change on the label: an ID number needs to be added next to the CE mark.

But it does not apply to all machines. Only machines placed on the market from January 20^th 2027 and where a notified body has performed the EU type-examination and issued an EU type-examination certificate for the machine.

The Machinery Regulation states that:

“the CE marking shall be followed by the identification number of the notified body involved in the [conformity assessment]“

So the ID number is only required if a notified body has been used for the conformity assessment. This can be seen in the Declaration of Conformity, and is also indicated by the product having an EU type-examination certificate. But sometimes a product can have a voluntary certificate, testing for similar standards and requirements. And this certificate can also be mentioned in the DoC, in which case the company certifying the machine is called a certification body. This means it is important to check if the DoC mentions a notified body or a certification body, and if the certificate for the machine is an EU type-examination certificate or a voluntary certificate.

The requirement for the ID number applies to machines as well as the safety components that are used in a machine. So you need to check the DoC of the safety component to see if a notified body has been used, in which case there should be an ID number next to the CE mark. But if the safety component was placed on the market before the new Machinery Regulation came into force, it does not need to have the ID number.

The new EU Machinery Regulation requires data logging for all interventions in safety-related software — especially for machines with self-evolving behavior.

Starting January 20^th 2027, if a change is made to the software of a safety PLC after the machine is put on the market, that intervention must be logged and stored for five years. This applies both to “local” changes done at site and to remote access changes. And if you have a system where AI or machine learning can make changes to safety-related software, all safety-related decisions must be logged together with the decision-making data, and stored for one year. National authorities can request these data in case of an accident.

The EU Machinery Regulation, together with the EU AI Act and the EU Data Act creates a comprehensive regulatory ecosystem for modern, digitalized machinery. Machine builders need to take all of them into consideration, depending on the level of digitalization of the machine.
The Machine Regulation defines how machines must be built, the AI Act defines how its intelligence must be governed, and the Data Act defines who gets to use the data it produces.

Machinery Regulation and AI Act

The MR focuses on physical safety but has requirements for how to safely integrate AI into the control system. The EU AI Act expands the requirements for when AI is used in high-risk systems (such as machine safety) with requirements on AI for e.g., risk management, data governance, technical documentation, record-keeping, instructions for use, human oversight etc.

Machinery Regulation and Data Act

The MR has several requirements regarding data access, sharing and protection – primarily addressing cybersecurity. The EU Data Act complements the MR with further requirements on data sharing, with the aim to make data more accessible and usable, encouraging data-driven innovation and increasing data availability. 

In most cases the scope of the Machinery Regulation will overlap with other CE directives or regulations on product safety. Examples include the Low Voltage and Radio Equipment Directive and the ATEX Directive. The Machinery Regulation also provides requirements on explosion risks that can arise from the use of a machine.

If the timing of the commissioning or placing on the market can be reliably predicted for a machine, the rules are simple: If the machine is placed on the market before January 20, 2027, the machine must comply with the Machinery Directive. When placed on the market from January 20, 2027, the Machinery Regulation must be complied with.

No. According to Article 51 paragraph 2 of the new Machinery Regulation, the Machinery Directive will no longer be valid on January 20, 2027. This means that existing machines with an EC declaration of conformity to the Machinery Directive may no longer be marketed or placed on the market.

Yes, if the functionality of the machine still complies with the requirements of the new regulation.

The new Machinery Regulation does not apply retroactively. It only applies to machines and safety components that are placed on the market from January 20^th 2027. A safety component bought before this date should comply with the Machinery Directive. It can be OK to use an old safety component in a new machine if the component fulfilled all requirements that applied to it at the time it was placed on the market. But the new machine still needs to comply with all the functional requirements in the Machinery Regulation.

For simpler safety components – like most sensors – where meeting the requirements in the new regulation does not involve changing functionality, it would be OK to use an old product in a new machine. The only changes after the new regulation are often an ID number next to the CE mark and an updated Declaration of Conformity. This does not affect functionality, and usage would be OK.

For more complex safety components – like programmable safety controllers – they are affected by new requirements on e.g., cyber security and data logging, and meeting these requirements means updates in functionality. Using such a safety component in a new machine is only OK if the product has been updated to comply with the new regulation, or if the machine fulfills those requirements in some other way.

All European language versions are available for download on the European Union website.