Effects on operators of production facilities and technical equipment
Machinery Directive 2006/42/EC (MRL) (PDF) was in clear need of revision. Many of the revised definitions make the Directive more compatible with the new legislative framework. Likewise, in my view, an expansion of the risk-based approach beyond the health and safety requirements previously contained in Annex I of the MD into the area of digitisation and networking was more than necessary to encompass the increasing legal uncertainties in the market relating to these elements of any modern manufacturing structure. These regulations are primarily aimed at manufacturers of machinery and the other products covered by the new ordinance. We have already provided details of the regulations in our news coverage.
By contrast, there is surprisingly little discussion of the impact on operators of the new Machinery Ordinance and, because it is integral to the definition of artificial intelligence systems, the AI Ordinance. It can be assumed that many companies use machines in their manufacturing facilities, integrate them into already existing systems and/or also collaborate in Industry 4.0 networks.
These companies are regularly not addressees of the MD and will also not fall under the new Machinery Ordinance. However, it is frequently overlooked that, even in the currently applicable version, the question of significant modifications to a machine has a long history of debate between legislators, accident insurance providers and operators. The term has been the subject of two different interpretative papers by the Federal Ministry of Labour and Social Affairs and its respective predecessors in Germany in the last 15 years alone. The objective was to enable operators to assess a technical modification to a machine. If a modification was then so serious that the manufacturer’s original conformity assessment was no longer complete, the operator became the manufacturer of a new machine with all the resulting obligations.
These regulations of the Federal Ministry’s 2015 interpretative paper (only in German) currently form, at least in Germany, the basis for an operator’s decision as to whether modifications initiated to an existing machine must lead to a reassessment of the product’s conformity.
The new Machinery Ordinance defines a substantial modification in the draft text, which is currently only available in the original English language:
“ ‘substantial modification’ means a modification of a machinery product, by physical or digital means after that machinery product has been placed on the market or put into service, which is not foreseen by the manufacturer and as a result of which the compliance of the machinery product with the relevant essential health and safety requirements may be affected”.
Before looking at the implications of this definition, I think it is worth looking at the definition of artificial intelligence systems. The definition is broad and identifies three ways in which software can be understood as an artificial intelligence system:
- any type of machine learning
- logical structures
- statistical methods
If you look at the current production landscape, you will find the latter two definitions on at least most of the machines used there. If we then combine the definition of substantial modification and that of artificial intelligence systems, it very quickly becomes clear that any use of monitoring systems on machines, sensor technology, predictive analytics as part of predictive maintenance, automatic sorting of defective parts, defect detection based on optical inspection systems – all constitute a substantial modification and an artificial intelligence system.
The frequent consequence is therefore that a conformity assessment process again becomes necessary, not by the manufacturer, but by the operator. As a rule, the latter will not be able to make this assessment for the machine itself, and even less so for the added software, which is classified as artificial intelligence in the AI Ordinance.
Whether, under these circumstances, operators will still be able to deploy expedient systems like the ones mentioned above without a lot of effort and expense is, in my opinion, less likely than before.
Whether the objective of the Machinery Ordinance will really have a beneficial effect may be doubted. Deliberations are underway on the Machinery Ordinance as well as on the draft AI Ordinance. Attention should be paid to the broad definition of a substantial modification as well as the broad definition of an artificial intelligence system.