How Regulation 2023/1230 affects product design.

EU Regulation 2023/1230 on machinery (Machinery Regulation), which will replace Directive 2006/42/EC from 20 January 2027, significantly changes the approach to design by requiring the integration of digital safety, artificial intelligence and new ergonomic requirements. This is no longer just mechanical safety, but a comprehensive approach to product safety throughout its entire life cycle.

Key aspects of the impact of Regulation 2023/1230 on product design:

1. Cybersecurity & Software

The design must ensure that machine control systems are protected against deliberate attacks that could lead to dangerous situations.

Update security: If the software is updated, the design must ensure that this update does not reduce the level of safety, even if the machine changes its functionality (self-learning/AI).

Particular attention should be paid to the reliability of software responsible for safety functions.

2. Artificial intelligence (AI) and autonomy

The regulation requires that machines with AI or self-learning functions be designed so that their actions are predictable and safe.

The design must take into account the risks for autonomous mobile robots (e.g. mandatory stop when a person is detected).

3. New requirements for ergonomics and operators

The design must minimise not only the physical but also the psychological stress of operators associated with interacting with the machine.

Safety requirements for human-robot collaboration have been strengthened.

4. Changes in physical design (mobile machines)

If there is a risk of overturning (ROPS), the machine must have restraint systems (seat belts), and if the seat belt is not fastened, the machine must not move.

The requirements for visibility from the driver's seat have become more stringent.

5. Substantial Modifications

If a modification to a machine (even an old one) during operation is considered ‘substantial’ under the new regulations, it must undergo a new conformity assessment procedure as if it were a new machine.

6. Digital Documentation

Design now includes the creation of digital operating instructions and technical documentation, which must be available, searchable and downloadable for at least 10 years.