The regulatory landscape for product safety is going through one of its most significant transformations in years, and manufacturers across every sector—industrial machinery, ICT and A/V, household appliances, components, laboratory equipment, and even transportation safety—are feeling the impact. And all signs point to one thing: regulators, on the whole, want more assurance of safety, better documentation, and proactive mitigation of risks. Time to adapt is now for companies readying themselves for the next wave of compliance obligations.
Most visibly, this shift begins with the new EU Machinery Regulation (EU) 2023/1230 replacing the long-standing Machinery Directive. That Directive served industry for more than 15 years, but the new Regulation brings in a much more harmonized and up-to-date framework. Manufacturers will no longer deal with national transpositions or varying interpretations. Instead, the obligations will be identical across all EU member states. This brings clarity—but also raises the bar.
One of the most important changes is the way the Regulation treats software-driven and connected machinery. Modern industrial equipment is no longer mechanical alone; it often includes digital control systems, remote connectivity, and even algorithmic decision making. With this reality in mind, the Regulation now calls for expanded evaluations of software safety, updates, cybersecurity risks, and how the equipment behaves when digitally connected. Most companies will have to improve their post-market surveillance processes, update their technical documents, and do a complete reassessment of risks. It will be the manufacturers who hold off until the last year who will face unnecessary trouble when the new rules come into effect in 2027. Manufacturers that perform gap assessments in 2025 and update documentation in 2026 will find the transition significantly easier.
In the ICT and audio/video industries, where IEC 62368-1 has quickly emerged as the preeminent international safety standard, similar pressure is starting to build. The new IEC 62368-1 is firmly grounded on the Hazard-Based Safety Engineering (HBSE) approach, whereas the previous IEC 60950 and IEC 60065 standards relied on component-level specifications. Rather than specifying component-level requirements, the standard emphasizes identifying energy sources, evaluating their potential hazards, and implementing appropriate protective measures (safeguards). This feature is a must for the use of ICT and A/V products today.
But this flexibility also means manufacturers must understand their design decisions more deeply. Many products still fail during evaluation due to incomplete creepage and clearance calculations, overheating under fault conditions, weak battery protection, or insufficient documentation. Early-stage safety planning—long before the device reaches the test lab—is now essential. Companies that integrate 62368-1 into the design phase avoid delays, reduce redesign cycles, and accelerate global market access.
Household appliances are facing their own transformations. What used to be “simple” devices—coffee makers, heaters, washing machines, food preparation equipment—are now high-energy, digitally connected, and often powered by efficient external power supplies or batteries. As appliances evolve, regulators are emphasising more robust insulation coordination, smarter thermal protection, enhanced EMC immunity, and better system-level reliability. The upcoming External Power Supply (EPS) regulation (Regulation 2025/2052) adds further expectations for energy efficiency and safe power conversion. What used to be minor design oversights (wiring routes, enclosure strength, overheating at abnormal conditions, or missing hazard markings) now lead to immediate compliance failure. This is why early pre-compliance testing has become one of the most valuable investments for manufacturers. Identifying a hotspot or a component deviation early prevents months of downstream rework.
In the transportation sector, another major shift is taking place. Breath Alcohol Ignition Interlock Devices (BAIIDs), which are installed in vehicles to prevent impaired driving, have been moving towards much tighter specifications, especially within the US via NHTSA and Transport Canada programs in Canada. These now need to show they can work in harsh environmental conditions: extremely cold starts, resistance to vibration and shock, tamper protection, secure event recording, and faster warm-up cycles. Sensors, firmware, and calibration systems are quickly improving, but regulators are equally quickly updating their requirements to ensure safety and performance validation matches innovation. Early alignment with updated testing requirements is a necessity for both manufacturers entering this field and updating current models to avoid bottlenecks due to regulatory constraints.
The message is the same across these sectors: safety is no longer something considered as a “final check” on the road to certification. It must be thought about early, documented extensively, and validated again and again. Be it the new Machinery Regulation, hazard-based ICT safety principles, new expectations from household appliances in the next generation, component reliability, laboratory equipment standards, or transport safety devices, the most successful organisations will be the ones who are planning ahead and approach compliance as an ongoing engineering discipline - not a last-minute formality.
Nemko stands ready to support the manufacturer in clearly, precisely, and confidently mastering this ever-changing landscape of international regulations. Our teams work with every type of product with one important commitment: making sure safety, performance, and compliance are designed in from day one.
If you want support in understanding these changes, developing compliance strategies, or preparing your products for upcoming requirements, feel free to get in touch with the Nemko team and subscribe to our technical regulatory updates. Safety is advancing—and we’re here to help you stay ahead.