For this purpose the original texts of the new regulation, the applicable standard, the positioning of tekom Deutschland e.V., the German association for technical communication, and the daily practice were collected.
The new Regulation on machinery
The new Regulation on machinery states clearly in chapter II, Obligations of economic operators, article 10 (7) and (8):
7. Manufacturers shall ensure that the machinery or related products are accompanied by the instructions for use and the information set out in Annex III. The instructions may be provided in a digital format. Such instructions and information shall clearly describe the product model to which they correspond. (...) In the case of machinery or a related product intended for non-professional users or that can, under reasonably foreseeable conditions, be used by non-professional users, even if not intended for them, the manufacturer shall provide, in paper format, the safety information that is essential for putting the machinery or related product into service and for using it in a safe way. (…)
(8) Manufacturers shall ensure that the machinery or related product is accompanied by the EU declaration of conformity set out in Annex V, Part A or, alternatively, manufacturers shall provide the internet address or machine-readable code where that EU declaration of conformity can be accessed in the instructions for use and the information set out in Annex III. section 1.7
Digital EU declarations of conformity shall be made accessible online for the expected lifetime of the machinery or related product and in any event for at least 10 years after the placing on the market or the putting into service of the machinery or related product.
EPAC standard DIN EN 15194:2018‐11
According to Zedler-Institut, the EPAC standard for electrically power assisted cycles, currently in force, has clearly stipulated the paper form for some time. In addition, it describes quite clearly the scope of the safety instructions to be supplied:
6 Instructions for use
Each EPAC must be supplied with a set of instructions for use in the language of the country in which the EPAC is destined to be supplied. In various countries local requirements relating to this kind of information may be valid (see EN 82079-1). It is obligatory that the instructions for use are made available in paper form. For more detailed information to enable access for vulnerable people the instructions for use should be available additionally in electronic form on demand.
...and this is tekom’s point of view
In his article “Die EU sorgt für Spannung” (The EU is causing tension), lawyer Jens-Uwe Heuer-James also comments on the form of the instructions for use in issue 05 (September/October 2023) of the trade journal "technische kommunikation" of Gesellschaft für Technische Kommunikation - tekom Deutschland e.V. (Translation): ”Digitalisation is controversial.“
Conclusion: tekom’s lobbying work has paid off, the campaigning for the entry into digital user information has landed on fertile ground. With the Regulation on machinery it is now possible to provide “digital instructions for use”.
However, be attentive, the comprehensive discussion of this approach has shown that digitalisation is not accepted everywhere. During the consultations, in particular consumers’ associations criticised the approach. The criticism of the associations was heard. For consumer products, the digitalisation of usage information in the sense of replacing paper documentation does not apply. It is only possible to provide consumers additionally with an offer of digital user information.
In the B2B sector, various requirements are formulated for digital instructions for use. All of them must be observed and fulfilled. First of all, it is the manufacturer's obligation to provide access to digital user information. By virtue of its wording this does not necessarily mean that information has to be provided on the internet. It is, however, assumed by the authors of the Regulation on machinery that this will probably be the preferred practice. More details, such as indications as to the access are currently still missing. However, it is probably the case that the easiest possible access is required.
Requirements to the provision
It must therefore be ensured that the access is available for the service life of the machine (ten years at least). There is a call for the use of a stable, future-proof technology. Likewise, spontaneous relocations of Internet pages without ensuring that existing access is forwarded are out of the question. It should also be noted that there is a requirement for comprehensibility with regard to the digitised instructions. It remains to be clarified in the future what that means in detail. Technical editing geared to the digital medium is necessary in any case. To simply provide huge text quantities as pdf-files will not fulfil the comprehensibility required.
Another important precondition is that the digital information can be stored and printed by the user. This should also apply to all information that is provided as help in the machine software (keyword “online support”). It should not be enough to simply use screenshots; a certain amount of content processing is expected. More precise criteria in this regard are currently however not available.
… and in real life?
According to Zedler-Institut, one simple lesson can be concluded from the applicable regulations and standards: B2B purely digital yes, B2C purely digital no.
When selling components to the bicycle manufacturer, the component manufacturer may supply digital component instructions. However, the bicycle manufacturer or his trading partner must provide the standard-compliant operating instructions for complex and ready-to-ride EPACs in paper form when selling them to the end consumer.
Furthermore, he is one hundred percent without initial suspicion for a trade or market surveillance authority if he will supply printed instructions for the bicycle/e-bike in the respective national language. What has also been realised successfully are hybrid concepts with printed, concise operating instructions in several languages referring via weblink or QR code to comprehensive, detailed instructions specifically according to EPAC/e-bike category. Instructions of the drive system and component suppliers were also made available within the “Technical support”. Both concepts were accepted without difficulties from the market surveillance and accident prevention authorities in many countries of the European Union, but also in the UK and Switzerland.
Text: Jo Beckendorff/Zedler-Institut