New opportunities for digital instruction
09 October 2023
The new machine regulation offers opportunities to provide digital operating instructions
At a time when digital transformation has become the norm, companies face the challenge of moving from printed manuals to online instructions. The advantages of digital manuals are obvious: They are environmentally friendly, cost-effective and promote user-friendliness. However, behind this seemingly simple transition lies a complex legal issue. European legislation spreads publication format requirements across different sources, leading to confusion. What about the new machinery regulation and the implications for user manuals? What do standards say about this and to what extent can augmented reality solutions replace paper manuals? In this blog, we dive deeper into the fragmented landscape of digital instructions and explore the legal and practical aspects.
The fragmented landscape of digital instruction
“Can you publish your manual online only?
In the world of user manuals, this is probably 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 usability, 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.
The requirements regarding the medium were never mentioned in the directives and regulations covered by CE marking in the past, but here and there you can find something about it in the Blue Guide, the specific “guides” that often accompany directives and regulations, or in standards.
The first significant shift toward digital occurred with medical devices. With the new regulation for machine products, is it now the turn of machines and does this present opportunities?
Digital instruction manuals according to the machinery directive
If we look at the current Machinery Directive 2006/42/EC, we find no requirements in it about the medium for the instructions. Is the directive clear on other issues, such as the obligation to translate the instructions?
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 hard copy. So that would mean that not everything has to be printed. So anything not related to health and safety would be allowed to be in digital form.
Can standards perhaps give us more information? By applying standards, you can demonstrate compliance with the requirements of a directive. A standard is not a hard obligation, but when a standard is applied, you create the so-called presumption of conformity with the relevant directives. The machinery directive says the instructions must be clear to the intended user. But how do you create a clear instruction manual? By applying standards!
Standard EN IEC/IEEE 82079 provides guidance on the content, structure, quality, process, media and format of usage information. The standard not only applies to a specific product or industry, but also contains cross-sectoral guidelines for almost all industries, from toys to medical devices and from electrical equipment to machinery.
The 82079 standard states that the format of the instruction manual should be based on the needs of the target audience. This can be interpreted to mean that digital formats allowed if the application or use of a product really demands it. In the case of low light, for example in a laboratory, the text in the instructions for use should light up. An electronic medium is then a logical choice. Another example is the use of paper in greenhouses or clean rooms, where it can get wet or disperse particles, respectively.
In addition to standard 82079, to meet the requirements for operating instructions as defined in the Machinery Directive, EN ISO 20607 has been developed. This standard specifies requirements for the machine manufacturer to prepare the safety-relevant parts of an instruction manual for machinery.
This standard says that instruction manual must be supplied in the form(s) as 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 instruction manual be printed, or at least the safety information. For machines, installation, maintenance instructions, spare part list et cetera are often also part of safety information, so savings are usually minimal.
The new machine regulation and implications for the user manual
Will this change when the new machine regulation comes into effect?
The new Machinery Directive was adopted in the European Parliament on 18.04.2023 and is expected to completely replace the current Machinery Directive from the end of 2026 / beginning of 2027.
What particularly stands out in the new regulation in the area of instructions is the section on the form of publication. Section 1.7.4 states the following:
Does this mean that when the regulation takes effect, it will be acceptable to provide the instructions for use digitally?
The central role of risk assessment
As in the current Machinery Directive, the new Machinery Directive describes in Annex III that the manufacturer (or his authorised representative) must ensure that a risk assessment is carried out at all times to determine the health and safety requirements applicable to the machinery. In simple terms, this means that your risk assessment must assess whether a digital instruction manual poses risks and, if so, whether these should be mitigated by providing a paper manual.
Despite conducting a risk assessment being a structured and standardized process, it often remains a subjective exercise. Whether a digital manual can (partially) replace the paper manual will ultimately have to be judged by the person conducting the risk assessment or the person ultimately responsible within an organization.
Can and may augmented reality replace the paper manual?
Digital alternatives to the paper manual abound, think video, HTML versions (online help) or, of course, instructions via augmented reality (AR). AR allows users to see digital content over the real world, making for a more intuitive and intense experience. Instructions can be presented in context, making it easier for users to understand and follow the steps.
The current situation with products such as commercial machinery, vehicles and other complex products that require maintenance is that they require a trained technician. Especially for products that require installation or maintenance, there are opportunities to apply AR that can also be safer than the paper alternative.
AR or mixed reality can be a better solution in cases like this. Instead of sending a crate of a machine and then flying in a technician, you could send a mixed reality headset or augmented reality app instead of the technician. This way, customer personnel can be supported in installing, training and troubleshooting, all without a technician having to leave headquarters.
The content for this manual still needs to be developed. Total Reality and INSTRKTIV can support you in this process. Want to know more about using augmented reality in manuals? Check out our page on AR manuals.
Ferry Vermeulen is director at INSTRKTIV BV and lecturer at the NEN. It is Ferry’s mission with INSTRKTIV to create digital instruction manuals for all products in the world, taking into account legal requirements.