Question 1

Why is there a new EU Machinery Regulation?

Accepted Answer

The Machinery Regulation EU 2023/1230 replaces the previously applicable Machinery Directive 2006/42/EC. The latter had been in force since 29 December 2009 and was therefore no longer in line with the current state of the art.

Question 2

Which machines does the new EU Machinery Regulation apply to?

Accepted Answer

In principle, the EU Machinery Regulation applies to all stationary and mobile machinery. Ships, motor vehicles, trains and aircraft are excluded, but machinery mounted on or installed in them is not.

Question 3

To whom does the new EU Machinery Regulation apply?

Accepted Answer

The EU Machinery Regulation applies to all manufacturers, importers and distributors who wish to place new machinery on the EU market from 20 January 2027 onwards. Whether this machinery was manufactured within the EU itself or abroad is irrelevant.

Question 4

What are the key changes introduced by the new EU Machinery Regulation?

Accepted Answer

The EU Machinery Regulation is directly applicable and binding in all EU Member States. It no longer needs to be transposed into national law. It is therefore a uniform standard across the EU.

New safety requirements

The new Machinery Regulation incorporates protection against cyber attacks as well as the use of AI and digitalisation to enhance machine safety. Safety components containing digital elements must therefore comply with all relevant requirements relating to cybersecurity and tamper protection. The key changes and requirements are:

High-risk machinery: Machinery and safety components with embedded AI are classified as high-risk and are subject to strict safety requirements and conformity assessments.
Cybersecurity measures: Access controls, encryption and security updates protect control systems against tampering and cyberattacks.
Safety-related software: Not entirely new – but now addressed in clearer terms – is the topic of safety-related software. If such software is placed on the market as a standalone product, it is regarded as a safety component and is therefore subject to the rules of the Machinery Regulation. In the vast majority of cases, for example, function libraries for programmable controllers are currently tested and certified together with the relevant hardware. However, if such components are offered separately by third parties, for instance, they must be accompanied by a declaration of conformity and bear the CE marking.

Question 5

What happens if my machine does not comply with the EU Machinery Regulation?

Accepted Answer

Machinery that does not comply with the EU Machinery Regulation 2023/1230 may no longer be sold in the EU from 20 January 2027.

Question 6

What is the difference between the EU Machinery Regulation and the Cyber Resilience Act (CRA)?

Accepted Answer

The Cyber Resilience Act applies to all products containing digital elements, including mobile machinery equipped with digital components. The Cyber Resilience Act supplements the Machinery Regulation.

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