New Machinery Regulation, the entry into force approaches: what’s new for Manufacturers

THE 2027 DEADLINE

As of 20 January 2027, compliance with cyber threat protection requirements will no longer be an option or a best practice, but a binding obligation for placing any machinery on the European Union market. This paradigm shift reflects the growing interconnection of industrial facilities and the need to prevent attacks that could compromise worker safety.

WHAT THE MANUFACTURER MUST PROTECT

The new regulation focuses on protecting everything vital to the machine’s proper functioning. Specifically, manufacturers must ensure that:

• No connection (remote or local) becomes a gateway to alter the machinery’s safety functions;
• Software and critical data must be protected against tampering, whether accidental or intentional (cyberattacks);
• Control devices must be designed to withstand unauthorized access attempts.

THE PATH TO COMPLIANCE

To comply with the new regulation, the design process must include three fundamental steps:

1. Implementation of countermeasures: Adopt technical solutions (such as encryption, authentication, and logging systems) to neutralize or mitigate identified risks.
2. Cyber threat analysis: Identify potential attack vectors specific to the type of machinery and its intended use.
3. Risk assessment (ISO 12100): Integrate digital risks into the traditional mechanical and operational risk assessment.

BEYOND HARDWARE: SOFTWARE AS A SAFETY COMPONENT

Another major change is the recognition of software as an actual safety component. If software performs critical functions, it must be accompanied by its own technical documentation and, in some cases, independently CE marked. Post-sale updates must also be managed carefully: significant software modifications could constitute a ‘substantial modification’, requiring a new certification of the entire machinery.

WHY ACT NOW

Regulation 2023/1230 pushes manufacturers toward a holistic vision of safety and security: it is no longer enough for a machine to be ‘physically’ safe, it must also be ‘digitally’ secure. Preparing today means analyzing your systems, updating design procedures, and ensuring that your products are ready for the technological challenge of 2027.

Those who choose to act ahead of time, leveraging expert support, can drastically reduce the risk of delays and unforeseen costs.

In this increasingly critical landscape, Ente Certificazione Macchine (ECM) positions itself as a qualified partner to support companies in achieving and maintaining machinery compliance.

Our mission is to ensure that every system, from individual machines to complex production lines, meets the highest standards of efficiency and safety.

Contact us now to assess your machinery!