The new machinery regulation and the implications for user manuals

On 19 June 2023, Regulation (EU) 2023/1230 on machinery was published in the EU Official Journal. This “machinery regulation” will fully replace the current machinery directive 2006/42/EC in January 2027 after a transition period. With respect to user instructions, the main change is that making them available in a digital format will be allowed. This article gives an overview of all the changes in the new machinery regulation compared to the machinery directive in relation to the user instructions and goes into a bit more detail about digital manuals. It also describes what to think about when you want to write a user manual for a machine.

No clear European legislation on the format of user instructions

In the world of technical communication, the question of whether user manuals are allowed to be published online rather than printed is by far the most frequently asked question we have heard over the past 15 years. No doubt this is because companies see that online manuals have many advantages over their printed counterparts. 

Since the rise of digital media, the paper manual has increasingly become an obstacle for anyone who takes user-friendliness, efficiency, the environment, or cost savings seriously.

If we approach the above question from a legal perspective, a seemingly simple question turns into a complex one in an instant. This is because publication format (medium) requirements are unclear and fragmented across different sources of European legislation. 

In the past, the requirements regarding the medium were never mentioned in the directives and regulations falling under CE marking, but here and there some information can be found in the Blue Guide, the specific "guides" that often accompany directives and regulations, or sometimes in standards. 

The first significant shift towards digital occurred for medical devices through Regulation (EU) No 207/2012 "on electronic instructions for use of medical devices." The upcoming machinery regulation also finally offers opportunities for the digital provision of user manuals. However, not without risks.

Current machinery directive on digital operating instructions

Looking at the current machinery directive 2006/42/EC, we do not find in it any requirements on the medium for operating instructions. On other matters, such as the obligation to translate operating instructions, the directive is clear.

A guidance document is also developed for almost every European directive. For the machinery directive, this is the Guide to application of the machinery directive 2006/42/EC. This guide explains the concepts and requirements of the machinery directive to ensure uniform interpretation and application. 

This guide states in §255 that it is generally accepted that all instructions relating to health and safety should be provided in paper form.

So that would mean that not EVERYTHING needs to be printed. Everything not related to health and safety could potentially take a digital form. 

Could standards perhaps give us further information? By applying standards, you can demonstrate that a product or machine meets the requirements of a directive. A standard is not a hard obligation, but when a standard is applied, you create what is known as a “presumption of conformity” with the relevant directives.

To meet the requirements for operating instructions as stipulated in the machinery directive, standard EN ISO 20607 has been developed. This standard specifies requirements for the machine manufacturer to draft the safety-relevant parts of an instruction manual for machinery and should be considered a complement to EN IEC/IEEE 82079-1.

EN ISO 20607 says that instruction handbooks for a machine should be supplied in the form(s) agreed with the customer, with the manufacturer being aware of the applicable legal requirements of the country in which the machine is first placed on the market and/or put into service. 

Most countries require that either the entire instructions be printed, or at least the safety information. For machinery, the installation instructions, maintenance instructions, spare parts list, et cetera are often also part of the safety information, so paper savings are usually minimal.

The new machinery regulation on digital user manuals

New machinery legislation was desired to reflect the current state of the art. Topics such as cybersecurity and artificial intelligence are not addressed in the machinery directive.

Regarding the user instructions, the most notable change is that digitization of documentation will be allowed. The regulation says the following about this:

Instructions and other relevant documentation may be provided in a digital printable format. However, the manufacturer should ensure that distributors can provide, at the request of the user at the time of the purchase, the instructions for use in a paper format free of charge. The manufacturer should also consider providing the contact details where the user can request the instructions to be dispatched by mail. 

Furthermore, the regulation states that when the instructions are provided in digital format, the manufacturer must indicate on the machinery how to access the digital instructions. In addition, the user must be able to print, download, and save the instructions.

The instructions must be available for the expected lifetime of the machinery and for at least 10 years after the machinery has been placed on the market. 

If the user requests paper instructions at the time of purchase, these must then be supplied free of charge within one month by the manufacturer. If the user does not expressly request it, the instructions may be provided digitally.

If machinery is intended for non-professional users, or if it can reasonably be expected that a given machine can be used by non-professional users even though it is not intended for them, the manufacturer must provide in printed form the safety information essential for commissioning and safe use of the machine. In addition, of course, the requirements imposed by the machinery regulation on the content of the user manual must be observed.

The role of a risk assessment

Does this mean that all instructions can just be put online if the user does not ask for them? We think not. 

The new machinery regulation describes in Annex III that the manufacturer of a machine must carry out a risk assessment. 

In the risk assessment one should assess whether a (partially) digital instruction manual creates a risk and, if so, whether measures should be taken to reduce the risks, for example by providing a paper manual.

Although conducting a risk assessment is a structured and standardized process, it often remains a subjective exercise. Whether a digital manual can (partially) replace the paper version is ultimately determined by the person carrying out the risk assessment or the person ultimately responsible within an organization.

Conclusion: Only if your risk assessment shows that it is safe to provide instructions in digital form can you do so.

Other changes regarding user instructions

The possibility of providing the user manual digitally is definitely the most important change with regard to user instructions in the new machinery regulation. There are also a number of other notable differences compared to the current machinery directive. 

For example, the requirement from the machinery directive that it must be clear that the instructions accompanying the machinery are "original instructions" or a "translation of the original instructions" has been dropped. 

Under the new regulation, the complete declaration of conformity no longer has to be included in the user instructions. It is sufficient to include an internet address or the machine-readable code where the declaration of conformity can be found.

The new regulation also includes a requirement to provide information “on the necessary precautions, devices and means for the immediate and gentle rescue of persons”.

The machinery regulation also emphasizes that if emissions of hazardous substances from the machinery may be released, the characteristics of the capture, filtration, or discharge devices must be indicated.

Finally, the machine manual expressly states not only that the health and safety of persons must be ensured, but also that the safety of domestic animals, goods, and the environment must not be endangered. This must therefore be taken into account while drafting the user manual.

How to make a good manual

Section 1.7.4.2 of Annex III in particular gives requirements for the user instructions. In addition, the machinery regulation states that the instructions must be “clear, understandable and legible.” If the manual is not understandable and results in risks, you can be held liable as a manufacturer. 

But how do you create an understandable instruction manual that meets the legal requirements? You do that by applying standards!

The very first standard that provides guidance is EN IEC/IEEE 82079. This standard provides guidance on the content, structure, quality, process, media, and format of operating instructions. The standard is a so-called horizontal standard and applies to almost all types of products: from construction products to toys and from medical devices to machines. 

As the 82079 does not sufficiently take into account the requirements of the machinery directive, the aforementioned EN ISO 20607 has been developed. This standard will be revised in the coming years to align with the new machinery directive.