The European Machinery Directive 2006/42/EC was set up to
- Guarantee a high level of protection for EU workers and citizens
- promote the free movement of machinery within the single market
One of the goals was to establish broad safety objectives for manufacturers and distributors of a wide range of mechanical equipment where manufacturers need to demonstrate compliance with certain regulation. Therefore, the scope is “machinery”, in a wider sense, as well as interchangeable equipment, safety components, but also removable mechanical transmission devices and partly completed machinery.
However, some applications are explicitly not addressed, as they are regulated separately. Examples include tractors, motor vehicles, medical devices and toys.
Why a revision?
The ongoing revision process was initiated as the current version needs updating to further improve safety levels and take account of the latest IT innovations. To ensure a consistent legal framework, the aim is to align the Directive with EU-harmonised legislation on product health and safety and at the same time to tackle challenges that may arise from technical progress in digitisation.
One of the fundamental changes is the legal form: converting the Directive into a Regulation. While a “Directive” sets objectives that all EU countries must reach and translate into their national legislation within a defined time frame, a “Regulation” is a binding legislative act, immediately applicable in its entirety in all Member States (overruling national laws).
Improvements in the current proposal
Besides the aim of coherence with the wider EU framework, the European Commission aims to improve legal clarity in the scope and definitions and reduced administrative burden and additional costs for operators. A major point here is that documentation in digital form is now allowed (previously a printed version was standard), and a paper form only needs to be provided if requested by the customer, while authorities now accept digital documentation. This represents a considerable saving of effort and costs. Another aspect addresses the technical progress in digitalisation, where the EC’s Communication on AI referred to the Directive as the EU’s central safety framework for AI robots, tackling autonomous behaviour of AI systems and robots and to cyber threats. This will ensure consistency with the Commission’s work strands related to AI.
What does it mean in practice?
From a viewpoint of a robot system integrator, the proposed changes are not fundamental – still no “certification obligation” for robot systems. However, new aspects of AI are included. AI in the context of functional safety is categorised as requiring certification in the sense of Annex I, which will make the approval and use of AI in safety-related applications very complex.
The 2006 version already mentions “Logic units to ensure safety functions”, in the proposal “New Software ensuring safety functions, including AI systems” and “New Machinery embedding AI systems ensuring safety functions.” are explicitly mentioned.