Machinery Regulation – Read Everything You Need to Know 

A major change is on the horizon for machine designers: the familiar Machinery Directive will be replaced by the new Machinery Regulation on January 20, 2027. But what does this mean in practice, and how should you prepare? 

The EU Machinery Regulation will replace the Machinery Directive that designers have long been used to working with. Strictly speaking, the Regulation is already in force and is partly applied by authorities. For manufacturers, however, the key date is January 20, 2027 – after that all new machines must comply with the Machinery Regulation. Before that the Directive remains valid. 

There will be no overlap time between the two, which means the transition period is already underway. 

Why is the Directive turning into a Regulation? 

The difference between a directive and a regulation is significant. A directive defines the outcome that member states must achieve but leaves it to each country to implement through national legislation. A regulation, on the other hand, is directly binding in all EU member states – immediately and without room for interpretation. 

From 2027 onwards, machine safety legislation will, for the first time, be fully harmonized across the EU. Updates to the legislation will also become faster and simpler, since member states will no longer need to amend their national laws separately each time changes are made. 

What’s new in the Machinery Regulation? 

While many familiar requirements remain in place – such as safe design, conformity assessment, sufficient documentation, and CE marking – the Machinery Regulation introduces some major changes: 

• Electronic technical documentation: Digital versions are now permitted, but manufacturers must still provide free paper copies upon request. Operating instructions integrated into the user interface must also remain accessible even if the machine is damaged. 

• New health and safety requirements: For example, machines requiring seat belts may not move unless the belt is in use. In addition, physical and psychological strain must be eliminated or minimized. 

• Software requirements: Software that impacts machine safety must be included in the technical documentation, along with source code and update information.

Risk Assessment and Declaration of Conformity 

Unlike the Directive, the Regulation requires every protective measure to be documented with a clear link to the specific health or safety requirement it addresses. Manufacturers must also consider risks arising from self-developing behaviour or machine logic, which may be a challenge for some. 

The Declaration of Conformity will also change. It must now include a statement that the declaration is made under the sole responsibility of the manufacturer and specify exactly which parts of standards have been applied if only partially used. In practice, this calls for more precise requirement definitions before design and thorough documentation during the design process. 

This is not just bureaucracy: careful documentation makes later product development easier and supports safety assurance throughout the machine’s lifecycle. 

When Do You Need External Assistance? 

Under the Machinery Regulation, the list of machines that require external assistance for conformity assessment is divided into two categories. The EU will update this list every five years based on data from member states on accidents, injuries, near misses, health issues, and identified safety shortcomings. 

The aim is that changes will be driven by real risks rather than fears or overly cautious restrictions. 

Prepare for the Machinery Regulation with Huld’s Experts 

The Machinery Regulation introduces additional documentation requirements – and it pays to prepare now. Many designers will need to become more familiar with documentation practices, but the fundamental principles of machine design remain largely the same. 

Now is the right time to make sure your organization’s processes and documentation are ready for the change. 

Huld’s experts can help you prepare smoothly and efficiently for the new requirements. Get in touch, and let’s ensure that documentation, risk management, and compliance are in place for every one of your projects. 

Contact:

Jasperi Kuikka 
+358 45 349 0665 
jasperi.kuikka@huld.io