The European Association for Technical Communication – tekom Europe e.V. is a multinational association and a forum for about 9,000 professionals across Europe who are active in technical communication and related fields. Among these professionals, tekom Europe counts over 2,680 machinery manufacturers, suppliers for machinery manufacturers, and consulting/service companies related to the business of machinery manufacturing. Our members develop all kinds of information for use for products, such as 

• Instructions for use, assembly, disassembly, maintenance and repair 
• Technical construction files
• Product labels or warning messages on products

tekom Europe welcomes the European Commission’s proposal for a new regulation on machinery products but also has some concerns. tekom Europe sees a need for clarification and amendment of the current draft (after consultation within the European Parliament). For the upcoming trilogue/interinstitutional negotiations in 2022, tekom Europe highlights the following positions:

• tekom Europe welcomes the alignment with the NLF and supports the proposed wording:  ‘Manufacturers shall ensure that the machinery products are accompanied by the instructions and information set out in section 1.7 of Annex III in a language which can be easily understood by end users, as determined by the Member State concerned. Such instructions and information shall be clear, understandable, intelligible and legible.’
• tekom Europe supports instructions in digital formats being allowed explicitly in the regulation for all kinds of instructions, e.g. assembly instructions.
• tekom Europe appreciates and supports the clear definition of ‘instructions’, which is applicable to format and media-independent. In the regulation, the intended definition stands for ‘instructions for use’; however, as explained below, tekom Europe suggests the term ‘instructions’ instead of ‘instructions for use’.

tekom Europe also sees more specific needs for clarification and amendment regarding the following issues:

1. tekom Europe sees the need for clarification of the terms ‘end user’, ‘non-professional operator’, ‘operator’ and ‘user’

Proposal:

Definitions for the terms ‘end user’ and ‘non-professional operator’ should be amended to the definitions listed in Article 3 and the use of the terms ‘user’ and ‘operator’ in the regulation needs to be reviewed.  

tekom Europe’s proposals are as follows:

• ‘End user’ shall mean any natural or legal person residing or established in the European Union to whom a product has been made available, either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities. Comment: This definition is already established in REGULATION (EU) 2019/1020 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011.
• ‘Non-professional operator’ shall mean any operator untrained in the use of the specific machine or related product or having no knowledge or background with regards to such use and is therefore not deemed a sophisticated user.
• The meaning of the term ‘operator’ in ANNEX III ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION OF MACHINERY OR RELATED PRODUCTS is not applicable to the term ‘operator’ in the main text of the regulation. To use the same term with different meanings in the same regulation is confusing. Therefore, the use of the term ‘operator’ in the main text needs to be reviewed to avoid confusion and misinterpretation. 
• ‘User’ is not defined and the use of the term is not clear. Who is meant with the term ‘user’ as used in the regulation? A differentiation between legal and natural persons is needed. A natural person is a physical person who interacts with the machine and its related product.    

Substantiation:

Definitions must be clear. This delimitation/differentiation is also important for bodies notified and national market surveillance authorities. Regarding the definitions of ‘end user’ and ‘non-professional operator’, the concepts of ‘foreseen and reasonably foreseeable use’ or ‘reasonably foreseeable misuse’ are of importance as worked out in Annex III, 1.1.2:

• 1.1.2. Principles of safety integration
  (a) A machinery product shall be designed and constructed so that it is fit for its function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof.

2. tekom Europe sees the need to use the term ‘instructions’ in a consistent manner in the regulation – it is important not to use other terms as ‘instructions for use’ or ‘instruction manual’. The definition of ‘instructions for use’ is then the definition for ‘instructions’ in Article 3.  

3. tekom Europe emphasises in ANNEX III the importance of the paragraph

• 1.7.4 Instructions  By way of exception, the maintenance instructions intended for use by specialised personnel mandated by the manufacturer or his or her authorised representative may be supplied in only one official language of the Union which the specialised personnel understand.
• Proposal: Any deletion of the paragraph should be reversed. And the text should be as follows:
  By way of exception, the maintenance instructions intended for use by specialised personnel mandated by the manufacturer or his or her authorised representative may be supplied in only one official language of the Union which the specialised personnel understand. Additionally other languages can be delivered on demand.
• Substantiation:  
  This exception has proven itself in practice and should not be changed or deleted. A change or deletion does not increase the safety level. On the contrary, if the specialised personnel do not speak the language of the country of destination, the safety risk is increased even more greatly.  

Dr Gabriela Fleischer European Association for Technical Communication – tekom Europe e.V. European Transparency Register identification number: 194995512904-93 Rotebühlstraße 64 70178 Stuttgart GERMANY g.fleischer@tekom.de +49 711 65704-70

Dr Tiziana Sicilia Chairperson of the European Association for Technical Communication – tekom Europe e.V.

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:

1. Direct delivery, for example, embedded in the machine control or on a separate data carrier, such as a USB stick.
2. 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:

1. Suitability
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)

2. Availability
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.

3. Presentation
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)