The benchmark is the new EU Regulation 2023/1230, which establishes a strict deadline: from January 20, 2027, every piece of machinery must comply with rigorous requirements for protection against cyberattacks.
CYBERSECURITY AS A BINDING OBLIGATION
Until now, safety was primarily understood as mechanical or functional protection. Under the new regulation, cybersecurity is integrated into the risk assessment process already familiar to manufacturers.
The Regulation clarifies that vulnerabilities and external attacks can compromise existing protective measures, making the machinery unsafe even without the emergence of new, obvious physical hazards. The focus therefore shifts to critical assets: software and data that can influence operational safety must be protected from manipulation, whether accidental or intentional.
TOWARDS THE EN 50742 STANDARD: ACTIONABLE GUIDELINES
To support manufacturers through this transition, the future harmonized standard EN 50742 is currently under development. This standard will define practical rules for protecting relevant components and data, providing examples and annexes for identifying and implementing countermeasures. The compliance process will consist of three main phases:
- Specific assessment of cyber threats;
- Risk assessment in accordance with the ISO 12100 standard
- Definition of the Security Context
WHY ACT NOW
Although the standard is still in draft form and the mandate will not take effect until 2027, waiting is not a winning strategy. Adapting design processes requires time and specific expertise. Those who choose to act early, leveraging expert support, can drastically reduce the risk of delays and unforeseen costs.
In this increasingly critical scenario, Ente Certificazione Macchine (ECM) stands 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!
Your Partner in Quality, Safety, and Compliance
The life sciences sector requires specialized knowledge and reliable support. With our broad expertise, we help organizations comply with laws and regulations, ensure quality, and continue to innovate with confidence.
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