New Regulation on Machinery

© EU Regulation

Regulation (EU) 2023/1230 of the European Parliament and of the Council

of 14 June 2023

on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC

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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 digital form. Such instructions and information shall clearly describe the product model to which they correspond.

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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.

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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.

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The German Association for Technical Communication Tekom takes position

© technische kommunikation / tekom

Lawyer Jens-Uwe Heuer-James also comments on the form of the instructions for use in the September/October issue of the special-interest magazine "technische kommunikation" of Gesellschaft für Technische Kommunikation - tekom Deutschland e.V. (translation):

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Digitalisation is controversial

Tekom’s lobbying work has paid off and 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, the comprehensive discussion of this approach has shown that digitalisation is not accepted everywhere. During the consultations, consumers’ associations in particular criticised the approach. The criticism of the associations was respected. For consumer products, the digitalisation  of usage information in the sense of replacing paper documentation

 

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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 which 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

Furthermore, it must be ensured that the access is available for the service life of the machine, but at least for ten years. 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 however 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 (“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.

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Author: Jens-Uwe Heuer-James

Notes on the actual practice of operating instructions

The most important thing to conclude from the applicable regulations and standards is: B2B purely digital yes, B2Cpurely digital no.

Based on the facts, the bottom line is 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 their trading partner, on the other hand, must hand over the standard compliant operating instructions for fully assembled and ready-to-ride e-bikes in paper form when selling them to the end user. This means that this job is in the responsibility of the

 

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brand or the fully-assembled bicycle manufacturer.

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

 

© Zedler-Institut

This is in fact not always realisable. With some manufacturers with international supplies we have successfully realised hybrid concepts in the past years. In other words, relatively concise operating instructions in several to many languages were printed. And this printed manual was or is supported by weblink or QR code by 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. In this way, the manufacturers, together with us, have managed the three-dimensional balancing act of cost efficiency, customer service and release from liability.

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

 

And what about sustainability?

For those who are not only thinking about the expenses, but also about sustainability, we would like to remind them that the production of the instructions we supply is certified climate-positive.

The printing on FSC® mix paper is realised with photovoltaics, additionally purchased electricity from hydro and wind power and by using eco-colours. Last but not least we are planting trees as part of a reforestation project in Germany to compensate for logging and transport by truck, as reported. In 2022 alone, we planted 3,632 oaks, 312 larches and 434 wild apple trees.

Photo: Zedler-Institut