In fact, the use of digital-only documentation poses a risk for manufacturers. In the Regulation on Machinery, the White paper only just published on this subject and the harmonised EN 15194 standard it is stipulated quite differently. The paper form for essential parts of operating instructions is still required. Purely digital documents are likely to be rejected in court or by a market surveillance authority, which can lead to expensive consequences.

 

To give you an idea of the situation, we have compiled excerpts from the relevant passages of the new regulation and the applicable harmonised standard. The texts are the original ones, the only change that was made is highlighting in bold.

 

The German association for technical communication – tekom Deutschland e.V. is also very critical about ‘purely digital’. In this regard we also compiled excerpts from the editorial article “Die EU sorgt für Spannung” (The EU creates tension) published in the association’s magazine “technische kommunikation” (technical communication).

 

 

REGULATION (EU) 2023/1230 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

 

 

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.

(…)

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 ... 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 ...

 

 

 

Meaning of ‘safety information that is essential’ mentioned in the fourth subparagraph of Article 10(7) of the new Machinery Regulation:

 

It is understood that such information should, as a minimum, consist of information relating to assembly, start-up, use, maintenance and transport of the machinery, ensuring that, by following those instructions, the safety or health of the user or a third person is not at risk. This information should be consistent with the instructions for use.

 

 

(…)

 

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.

(…)

 

 

 

Lawyer Jens-Uwe Heuer-James commented 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

(...)

 

However, 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.

(…)

 

Author: Jens-Uwe Heuer-James

 

 

 

The most important thing to conclude from the applicable regulations and standards is: B2B purely digitally – yes, B2C purely digitally – no.

Based on the facts, it can be concluded that digital component instructions are legal when components (drive systems, brakes, wheels, etc.) are sold by the supplier to the bicycle manufacturer.

 

The bicycle manufacturer or its trading partner, on the other hand, must hand over the standard compliant operating instructions for fully-assembled and ready-to-ride e-bikes, e-MTBs and e-cargo bikes in paper form when selling them to the end user. This means that this job is in the responsibility of the brand or the manufacturer of the fully-assembled bicycle.

 

As a bicycle manufacturer, you are one hundred percent without initial suspicion for a trade or market surveillance authority if you enclose printed instructions for the bicycle/e-bike in the respective national language.

 

This is in fact not always realisable. With some manufacturers that supply their products globally hybrid concepts have already been realised successfully in the past years. In other words, relatively concise operating instructions in several or many languages were printed. And this printed manual was or is supported by weblink or QR code with comprehensive, detailed instructions, of course specifically according to EPAC/e-bike categories. The instructions of the drive system and component suppliers are additionally 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. This is how the manufacturers have managed, together with us, the three-dimensional balancing act of cost efficiency, customer service and release from liability.

 

That is, however, not always the case. We have been learning that for some years now from the proceedings of the authorities that we accompany in Italy, France, Austria, Switzerland and, of course, the largest market for electric bicycles, Germany. This year alone, there have been already nearly ten.