Machinery Regulation from 2027: Security will be a key competitive factor

Jürgen Bukowski, Senior Manager Consulting & Services Operations

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The increasing digitisation and networking of industrial plants has changed the risk landscape. That's because classic functional safety is no longer enough to guarantee Machinery Safety in modern production environments. Cyberattacks, manipulation, and insecure remote access pose real threats. The Machinery Regulation (MR) addresses this development by merging Safety and Industrial Security. For businesses, this means that access to the European market will in future be linked to comprehensive Safety and Security requirements – and will therefore become a key competitive factor.

Implementation and key requirements
The MR calls for a holistic approach throughout the entire machine lifecycle. One key element is the consistent integration of Security by Design: protective measures against manipulation, unauthorised access or unsafe software changes must be considered as early as the construction and design phase.
At the same time, digital documentation is becoming increasingly important. Operating manuals and declarations of conformity must be provided in a digital format and must be kept available for a minimum of ten years. This requires new processes for documentation, data retention and traceability.

There is also a focus on clearly regulated update and remote access processes, as well as the ability to verify safety functions. Machinery must be designed so that safety-related functions can be tested in a way that can be traced. Diagnostic data plays a key role: not only does it provide information about error states, but it also enables events to be traced transparently – to determine why a safety function has been triggered, for example. This transparency is crucial in order to minimise downtimes and operate plants efficiently. 

The MR also regulates structural issues within the plant network more clearly. The MR provides clarity when converting “assemblies of machinery” (interlinked plants): for the first time, the concept of a “substantial modification” has been enshrined in law. When conversion work is carried out, existing tests and documentation for unchanged sections of the plant may be left as they are, provided the modification does not give rise to any new risks. 

Impact and need for action
The Machinery Regulation imposes clear responsibilities on companies and increases the pressure on them to take action. Anyone who connects several machines or partly completed machinery to form an assembly, creating new interface risks in the process, is legally regarded as the manufacturer of the entire plant. This gives rise to specific obligations:

• You are responsible for ensuring that all components work together safely and seamlessly (for example, a plant-wide emergency stop function).
• The risk assessment must cover the entire interlinked plant.

For manufacturers, the MR on the whole means that development, documentation and safety processes must be adjusted and that technical documentation must be available long-term. In turn, operators are required not only to ensure safety during operation but also to safeguard against cyber risks. 

Global impact: A ticket to the EU market
The MR has impact far beyond Europe. Manufacturers worldwide must adapt their products, processes and safety concepts in order to continue operating within the EU.

In particular, requirements relating to cybersecurity, digital documentation and safe software processes are setting new standards. At the same time, European practice – such as the frequent interlinking of machinery – demands a high degree of flexibility and integration capability.
This makes the MR an international frame of reference. It defines what will be regarded as the state of the art in Industrial Safety in future – worldwide.

Act now: use the MR as an opportunity
The Machinery Regulation is far more than just a regulatory adjustment – it marks a paradigm shift in Industrial Safety. Companies that act early can use the new requirements to optimise their processes, reduce risks and strengthen their competitiveness in the long term. The countdown is on – and the foundations for future-proof machinery are being laid right now.