The New EU Machinery Regulation

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.

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.

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