Most engineering specialists dealing with CE marking in the Machinery sector are already well familiar with the requirements of the current EU Machinery Directive 2006/42/EC. As part of the EU “better legislation” initiative, the Machinery Directive is undergoing an update. The new, updated fourth publication of the Machinery Directive will become law in the coming months. After the end of the transition period, the requirements of the new EU Machinery Directive will become applicable to all machinery products
Let’s have a quick look at the main changes introduced by the new Machinery Directive.
Firstly, there are new requirements concerning “substantial modifications”, including software updates. The entity that introduces the modifications, whether it’s the machine designer or integrator, is now obliged to perform an impact assessment to check if, and how, the change impacts the conformity.
Next up is the topic of AI and ML, for example machinery that includes AI systems which fulfil a safety function. This topic is already well addressed in other domains (mainly Automotive and Medical Devices), but the machinery domain has arguably been somewhat behind in terms of legislation and standardization. While the new Machinery Directive goes some way towards addressing this shortfall, it will certainly take some time for the harmonised standards to catch up. In practice, while there is a lot of interest in this area, safety assurance for AI in machinery is not yet mature enough for widespread adoption.
The other major area of change is the consideration of cybersecurity with an impact on safety. While this is not a new topic as such, the new Machinery Directive now has explicit requirements for this to be taken into account. In practice, the two areas have usually been considered separately. With the new requirements, it is necessary to go integrate the two competencies during the product development process. Not doing it this way creates a risk of leaving gaps in the assessment, and therefore difficulties with demonstrating conformance.
The functional safety team at Huld closely follows new developments in legislation and standardisation, and we remain at the disposal of our Clients to help them with any challenges that these new developments might cause.