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Digitalization of Documentation Under the EU Machinery Directive: What’s Changed with the Revised Guide

This blog was originally posted on 8th May, 2024. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY EMILIA ASSENZA, SENIOR TEAM LEADER AND REGULATORY COMPLIANCE SPECIALIST, COMPLIANCE & RISKS

Introduction

Progress is being made in favor of the digitalization of documentation, in light of the recent update made to the EU Guide to the Application of the Machinery Directive.

In fact, it is known that the new Machinery Regulation (EU) 2023/1230 has brought some significant innovations with regard to the possibility of providing information in a digital format and clarifies the conditions under which the instructions for use, the declaration of conformity, the declaration of incorporation and assembly instructions for partly completed machinery can be provided in a digital format.

With the update of the Guide (3rd update – Edition 2.3), the transition to digital documentation has been made possible under the current EU Machinery Directive, provided that compliance with the relevant Articles of the Regulation is ensured.

In this blog we discuss:

Instructions for use
Declaration of conformity
Declaration of incorporation of partly completed machinery
Assembly instructions for partly completed machinery

Instructions for Use

Article 10(7) of the Regulation specifies that the instructions for use may be provided in a digital format. When instructions are provided digitally, the conditions to be fulfilled are:

To mark on the machinery (or where this is not possible on its packaging or an accompanying document) how to access the digital instructions (e.g. QR code);
To present the instructions in a format that makes it possible for the user to print and download them for use and save them on an electronic device. This condition must also be met when the instructions are embedded in the software of the machinery;
To make the instructions accessible online during the expected lifetime of the machinery and for at least 10 years after the placing on the market.

In addition, if requested by the user at the time of purchase, paper instructions must be provided free of charge within one month.

It is also worth noting that, when the machinery is intended for non-professional users, the safety information that is essential for putting the machinery into service and for using it in a safe way must be provided in paper format.

According to the revised Guide, compliance with Article 10(7) of the Regulation is appropriate to ensure compliance when providing instructions for use in digital format.

The Guide also states that for machinery for non-professional users, it is recommended to include the following statement in the essential safety information or on the packaging or on the machinery itself: “The purchaser has the right to request to obtain, free of charge, the instructions for use in paper format”. This statement should include contact information (postal address and/or telephone) and specify how the instructions can be requested.

Clarification is also provided on the meaning of the “essential” information which must be provided in paper format. Such information should at least include “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.”

Furthermore, additional information might be considered essential based on the risk assessment of the manufacturer.

Declaration of Conformity

According to Article 10(8) of the Regulation, the Declaration of Conformity can be provided in digital format. In that case, manufacturers must provide the internet address or machine-readable code where that Declaration of Conformity can be accessed in the instructions for use and the information set out in Annex III.

The Guide to the Directive has confirmed that when the EC Declaration of Conformity is provided in digital format, the provisions of Article 10(8) of the new Machinery Regulation can ensure compliance.

It is also clarified that “The instructions for use and EC Declaration of Conformity do not have to have the same format and do not have to form an inseparate physical or digital document. The EC Declaration of Conformity may be provided in paper format even when the instructions for use are provided in digital format (see §255) and vice versa. Such instructions may contain the EC Declaration of Conformity itself, or the internet address or machine readable code, where the EC Declaration of Conformity can be accessed.”

Declaration of Incorporation of Partly Completed Machinery

The same approach has been adopted for the Declaration of Incorporation under the revised Guide. When the Declaration of Incorporation is provided in digital format, the provisions of Article 11(8) of the new Regulation can ensure compliance.

As per Article 11(8), when providing the Declaration of Incorporation in digital format, manufacturers must provide the internet address or machine readable code where that EU declaration of incorporation can be accessed in the assembly instructions set out in Annex XI.

Assembly Instructions for Partly Completed Machinery

The digital format is now allowed for the assembly instructions as well. In this case, compliance with Article 11(7) of the Regulation must be ensured. Similarly to what is advised for digital instructions for use, it is advised to add a statement on the packaging, in an accompanying document or on the partly completed machinery itself stating that “The purchaser has the right to request to obtain, free of charge, the assembly instructions in paper format”.

Additionally, the Guide specifies that “The Declaration of Incorporation and assembly instructions for partly completed machinery do not have to have the same format and do not have to form an inseparate physical or digital document. The Declaration of Incorporation may be provided in paper format even when the assembly instructions are provided in digital format (see §390) and vice versa. Such assembly instructions may contain the Declaration of Incorporation itself, or the internet address or machine readable code, where the Declaration of Incorporation can be accessed.”

The alignment with the provisions of the new Regulation was encouraged by the recent statistics of Eurostat which showed that in 2023 no less than 93% of EU households had internet access. These circumstances have prompted the digitalization under the existing legislation, thus allowing fewer costs and administrative burdens for economic operators as well as more environment-friendly choices.

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