The Importance of Information for Use in Electronic Form
tekom Supports Jointly Developed Position Paper
Information for use in digital form is already commonplace in many industries. First and foremost, the software industry has already been working mainly with electronically provided information for use for years.
As early as 2015, a tekom survey showed that 75% of all software companies surveyed had a print share of less than 25%, measured in terms of the total documentation volume. In contrast, 50% of the industrial companies surveyed had a print share of 75% or more.
The European Union initiated an advance in a very sensitive area – medical devices – years ago. Regulation (EU) No. 207/2012 on electronic instructions for use of medical devices regulates the conditions under which instructions for use of medical devices may be made available in electronic form instead of paper. However, the regulation has not been a resounding success. The requirements were considered too onerous by many companies. In particular, the stipulation that the paper version must be provided within 7 calendar days at the latest upon customer request was a K.O. criterion for many.
Most of the European Product Safety Directives make no statement on the paper/digital issue.
The legally non-binding guidance documents (Blue Guide, Guide to Application of the Machinery Directive) make outdated and questionable statements on this issue. This simply leads to legal uncertainty, which ultimately prevents the economy from developing further in this area.
The Machinery Directive is now being revised. This Directive also has an impact on other directives such as the Low Voltage Directive. A regulation of instructions in digital form in the Machinery Directive would spark other product safety directives.
For this reason, more than a year ago, numerous representatives of associations and larger industrial companies came together in a DKE working group chaired by Dr. Claudia Klumpp (tekom) to draw up a position paper. The position paper is aimed at politicians and shows that there is no way around clarifying instructions in digital form. The following persons contributed to the position paper:
- Kevin Behnisch, Head of Department Smart Technologies and Industry, VDE Testing and Certification Institute
- Artur Bondza, Head of Content & Product Information Management, Pepperl+Fuchs SE
- Udo Keul, technical editor of MTM documentation, Endress+Hauser SE+Co.
- Thomas Kraus, VDMA, Technology, Environment and Sustainability
- Matthias Kurrus, head of technical documentation, Sick AG
- Jens-Uwe Heuer James, attorney, Luther Rechtsanwaltsgesellschaft mbH
- Roland Schmeling, CEO of SCHMELING + CONSULTANTS
The position paper was introduced to the tekom Deutschland expanded board of directors as well as the assembly of delegates, where it was given full support. Please disseminate this position paper to help compel politicians to clarify this issue.
Position paper of the DKE AK 113.0.4 on providing instructions in digital form
The competitiveness of European industry in the digital environment requires instructions in digital form. The general conditions are currently unclear! In connection with the current revision of the Machinery Directive, we demand clarification of the use of digital instructions. This will promote innovation in European industry and strengthen digital sovereignty in Europe.
The European Commission aims to create a digital single market1. One of the pillars of the digital single market is unrestricted (unrestrained) access to digital products. This means making full and comprehensive use of the opportunities of digitalisation. Where applicable, this should also apply to information which is part of a product, such as instructions. The assumption that paper is the form of choice is not up-to-date and is also incorrect because the form of information must always suit the product and its users. Some products might even require several forms of information.
The Machinery Directive does not make any requirements regarding the form of the instructions, and its scope covers a large number of very different products: The range extends from individual components to complex machine systems and from tailor-made machines to series products. So far, however, the Guide to Application of the Machinery Directive has adopted a restrained attitude towards instructions in digital form:
- The Guide to Application of the Machinery Directive includes the following statement in § 255:
“Section 1.7.4 does not specify the form of the instructions. It is generally agreed that all health and safety related instructions must be supplied in paper form, since it cannot be assumed that the user has access to the means of reading instructions supplied in electronic form or made available on an Internet site.”.
- As an optional addition, the guide says: “However, it is often useful for the instructions to be made available in electronic form and on the Internet as well as in paper form, since this enables the user to download the electronic file if he so wishes and to recover the instructions if the paper copy has been lost. This practice also facilitates the updating of the instructions when this is necessary.”
The Guide to Application of the Machinery Directive still assumes that access to instructions in digital form or by accessing a website is not very common. However, the spread of smartphones, tablets, etc. shows a different, constantly increasing trend.
The statement in the "Blue Guide" in footnote 99 (EN) / 100 (DE) also raises questions and causes further problems:
“…Unless otherwise specified in specific legislation, whilst the safety information needs to be provided on paper, it is not required that all the set of instructions is also provided on paper but they can also be on electronic or other data storage format. However, a paper version should always be available free of charge for the consumers who request it.”
The approach of presenting only safety-related information in paper form disregards an essential context: Without a context for action, safety-related information can cause, rather than prevent, danger. Machine users may feel compelled to use the machine solely based on the safety-related information. The footnote falls short in this respect.
The Machinery Directive currently regulates only placing products on the market, but not their further provision in the supply chain. The approach of the Guide falls short. The revision of the Machinery Directive will ensure compliance with Decision No 768/2008/EC, so that the supply chain will also be covered in the future. The digital instructions provide economic operators with better conditions to fulfil their respective obligations efficiently and promote the European digital single market. For example, digital instructions can be provided better and more easily to the next economic operator in the supply chain – which generally improves availability. In addition, the distributor can also react better in terms of language and format to better meet the needs of machine users.
Regarding the application and practice of the Machinery Directive and the Guide, individual member states have often observed that the market surveillance authorities take a different approach.
For the sensitive area of medical devices, Regulation (EU) No 207/2012 regulates the provision of "instructions in electronic form". Legally affected parties report that the rules are not practical, and they therefore refrain from making them available in digital form. The regulation has thus failed to have the intended effect - the amount of paper is not decreasing but continues to increase.
Overall, a uniform policy regarding instructions in digital form is not yet apparent.
- In view of the foregoing, digital solutions cannot be implemented in a legally compliant manner.
- There is uncertainty on the part of the industry in the implementation of digital solutions.
- This uncertainty hinders technical innovation in companies on their path to digitalisation.
- There is a risk that market legislation deviates from the approach and intent of a digital single market.
- The digitalisation of everyday life is leading to changes in reading and research behaviours among the general population and machine users.
- Expectations regarding the integration of information in the economy have changed.
- Instructions in digital form are more sustainable than paper and achieve a much higher distribution.
Action is needed to provide certainty and reliability to economic operators and market surveillance authorities to encourage, rather than obstruct, the free movement of goods.
1Most recently specified as a request in the mission letter by president of the European Commission Von der Leyen:
“I want you to focus on building a real single market for cybersecurity, notably looking at certification, implementing rules on security of network and information systems, rapid emergency response strategies and other relevant areas. You should lead the work to build a joint Cyber Unit to better protect ourselves.”
Instructions in digital form are sustainable
They can be provided and distributed in any number. They are easily recovered when lost. There is no paper waste in case of updates. There is no need to print language versions that are not required, for example, for machines laid in stock which have instructions in more than 20 languages, although only one of the languages is required.
Instructions in digital form increase safety
Instructions in digital form enable the search function. Required information can thus be found much faster and can be kept up-to-date more easily.
Instructions in digital form can present information in context. They support user guidance through interactive content that allows users to monitor and ensure their success. Updated versions of the instructions can be provided and used immediately. Instructions in digital form ensure traceability as the information can be clearly assigned to the corresponding product.
Instructions in digital form facilitate the employer's occupational health and safety measures because the necessary information can be provided in advance of machine delivery or during commissioning.
Instructions in digital form support accessibility and can provide users with additional assistance
Instructions in digital form enable font enlargement or functions to read aloud. They can offer additional support for the user, such as chatbots, online help, tutorials or videos, links to further information or to websites where suitable spare parts and materials can be ordered, thus reducing the risk of incorrect orders.
Instructions in digital form are more flexible
Instructions in digital form can be made available offline by means of download and are available regardless of location. It is easy to switch between available languages. When creating overall documentation for complex machines which consist of individual components from different manufacturers, instructions in digital form can easily be integrated while retaining their context.
Instructions in digital form promote future technologies
Instructions in digital form support modern usage scenarios, such as the use of augmented reality glasses, digital training models in virtual reality, or remote services.
Unlike the classic paper form, which can fill rows of shelves, archive rooms and containers, there are no limits to providing instructions in digital form. Starting with electronic storage media, such as DVD or USB stick, information can also be integrated (for example, using an RFID chip) or be made available for download (for example, by scanning a QR Code). Mobile devices are now widely used in the industrial sector where they allow quick and direct access to instructions, online or offline. In more complex machines and systems with a human-machine interface, instructions are often integrated in the user interface.
If required, such digital opportunities can also be combined.
The preparation and provision of instructions are fundamental health and safety requirements of Annex I of the Machinery Directive. These requirements must be met by the manufacturer. There are essentially two options:
- Direct delivery, for example, embedded in the machine control or on a separate data carrier, such as a USB stick.
- Supply of the source for access to the instructions, for example, by QR code, bar code, RFID chip, etc.
In this case, the instructions must also be verifiably available to the user at the time of placing the product on the market.
The manufacturer decides on the provision form and technology to meet the legal requirements. When deciding which information to provide and in what form, the manufacturer must consider the following aspects:
- Target audience of the product
- Concrete usage situations
- Intended use of the product and reasonably foreseeable misuse
- Application of “state-of-the-art” technologies (if necessary by applying relevant standards)
- Contractual agreements
- Effectiveness of provision, so the information reaches the user safely
Instructions in digital form require a technology for display. The following must be observed to ensure the effectiveness when providing instructions in digital form:
What technology is suitable for the target audience and the specific usage situation? (Internet access; poorly lit working conditions, low visibility, or particularly bright environment result in requirements such as illuminated display; accessibility; consideration of specific consumer needs)
There must be a clear, valid, permanent and easy way to access the instructions for each product. For example, legacy download links must still be valid when creating a new website.
Basically there are two options:
1. Choosing a format that is already very widespread and suitable for future use
2. Providing the information with or on the product (providing hardware and software for presentation together with the product)