Last edit: 07/05/2024
THE DOUBT
By working everyday together with manufacturers of machineries, we get frequentily asked the question “is it mandatory to give to our customer the Instruction Hanbook of the machine in papery format?”
CONSIDERATIONS
The publication on 18 April 2024 of the Guide to the Application of the Machinery Directive 2006/42/EC clarifies the fact that the manufacturer of a machine is not obliged to provide the respective instructions for safe use and declaration of conformity in paper format.
This obligation was due to the fact that, at the time of the publication of the Machinery Directive 2006/42/EC, the use of the internet and other digital formats was not yet as widespread and accessible as it is today: consequently, in order to ensure that users of a machine had access to the respective Operating Instructions, the only viable option was to provide a printed version.
With the Machinery Regulation, published in 2024, this fact is recognised and, consequently, this obligation has been removed, not only because the means of communication have now evolved and become more widespread, but also to reduce the cost and environmental impact of providing manuals in paper format.
However, the new Regulation also recognises the fact that access to digital formats is still limited in some environments, so, in order to meet everyone’s needs, Article 10 of the new Regulation will state the following:
Article 10 – Paragraph 7 – Obligations of manufacturers of machinery and related product
[…] The instructions may be provided in a digital format. […] However, at the request of the user at the time of the purchase, the manufacturer shall provide the instructions for use in paper format free of charge within one month.
Today, in the EN ISO 12100:2010 standard is reported the following prescription:
Durability and availability of the documents: documents giving instructions for use should be produced in durable form (i.e. they should be able to survive frequent handling by the user). It can be useful to mark them “keep for future reference”. Where information for use is kept in electronic form (CD, DVD, tape, hard disk, etc.), information on safety-related issues that need immediate action shall always be backed up with a hard copy that is readily available.
From this prescription it seems like that today is possible to provide Instruction Hanbooks in papery format too but the standard precises that the informations regarding safety related aspects that need to be immediately available must be always supplied with an hard copy.
Either ways, in 2019 the standard EN ISO 20607 has been published. It deals with the drafting of the instructions hanbooks of machineries. It is alligned with the standard EN ISO 12100 but it clearly expresses that the instruction handbook must be provided in the form as agreed with the customer (papery and/or digital).
Finally, the New Machinery Regulation makes it clear that it is possible, by agreement with the customer, to deliver the Operation and Maintenance Manual only in digital format, but with certain restrictions.
Article 10 – Obligations of manufacturers of machinery and related products
When the instructions for use are provided in digital format, the manufacturer shall:
(a) mark on the machinery or related product, or, where that is not possible, on its packaging or in an accompanying
document, how to access the digital instructions;
(b) present them in a format that makes it possible for the user to print and download the instructions for use and save
them on an electronic device so that he or she can access them at all times, in particular during a breakdown of the
machinery or related product; this requirement also applies where the instructions for use are embedded in the
software of the machinery or related product;
(c) make them accessible online during the expected lifetime of the machinery or related product and for at least 10
years after the placing on the market of the machinery or related product.
However, at the user’s request at the time of purchase or up to 1 month after purchase, the manufacturer is obliged to provide the instructions in paper format free of charge.
The new edition of the Guide to the Machinery Directive published on 18 April 2024 states that as many as 93% of EU households today have access to the internet. Under these circumstances, and in light of the provisions of the new Machinery Regulation on the format of instructions, it can be assumed that compliance with these provisions, including the obligation to provide the essential safety information in paper format in the case of non-professional use, also ensures compliance with the corresponding provisions of the Machinery Directive.
CONCLUSIONS
The Machinery Directive, the law of reference for assessing the conformity of machinery for industrial use, stipulates that the manual must be provided in a paper version. In 2023, the text of the Machinery Regulation was published, which only allows the manual to be provided in a digital version. Unfortunately, the Regulation will only come into force in 2027. However, the publication of the new Guide to the Machinery Directive in April 2024 already allows these documents to be supplied in digital format. Therefore, as of today, we consider it no longer necessary to provide instruction manuals in paper format unless expressly requested by the customer.