The adaptation to the new Machinery Regulation is presenting significant challenges for companies across the industrial sector. These are the most relevant insights from the current technical clarification phase:

• The definition of “Substantial Modification” is creating a major legal shift. Under the new framework, any physical or digital change not foreseen by the original manufacturer that creates new hazards or increases existing risks requires a full new conformity assessment. In practice, this means the user (the industrial company) often becomes the legal “manufacturer,” assuming all civil and criminal liability for the equipment’s safety.
• The “Safety by Design” approach for AI and autonomous systems is now a priority. Experts are currently defining the limits of autonomy in software safety components to address emerging risks from Artificial Intelligence and IoT. Manufacturers must ensure that machines with “evolutive logic” remain within safe parameters, a challenge that requires integrating the Machinery Regulation requirements with the new AI Act.
• Cybersecurity is no longer optional for industrial machinery. Following the alignment with the EN 50742 standard, machines must be protected against remote unauthorized access that could compromise safety functions. This includes ensuring “Security by Design” where the device firmware blocks access until a strong, unique credential is set by the user during the first use.
• The transition to digital documentation requires robust infrastructures. The regulation now allows providing instruction manuals in digital format, but manufacturers must guarantee their online availability for at least 10 years. However, for non-professional users, essential safety information must still be delivered in paper format, forcing companies to maintain a dual documentation system.