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On 18 April 2024, the EU Commission published the new version of the guidelines for the application of the Machinery Directive 2006/42/EC. As part of the new edition, the guidelines were adapted to the effect that digital operating instructions are now also permitted. This adjustment follows the publication of Machinery Regulation (EU) 2023/1230, which already provides for this. Until now, the new edition of the guidelines has only been available in English.
Edition 2.3 of the Machinery Directive Guide primarily contains new provisions on the instructions and the EC Declaration of Conformity as well as the assembly instructions for partly completed machinery and the Declaration of Incorporation when provided in digital format. These provisions refer to the corresponding articles of the new Machinery Regulation (EU) 2023/1230, which came into force on 19 July 2023 and will apply from 20 January 2027.
Thus, the updated guidance clarifies that digital instructions can fulfil the legal requirements if they comply with Article 10(7) of the new Machinery Regulation.
Manufacturers can now also provide instructions digitally, but must ensure that users are clearly informed about how to access these instructions. In addition, as a minimum, this information should include details on the assembly, commissioning, use, maintenance and transport of the machinery to ensure that the safety or health of the user or third parties is not jeopardised by following these instructions. This information should be consistent with the operating instructions.
As some of the individual paragraphs are very extensive, the table below only lists the amended sections and the newly added text elements.
Tip: Using the Safexpert document comparison tool, you can conveniently open the old and new editions of the guide in StandardsManager as an interactive comparison table, filter for amended sections and display the sections directly next to each other in full text.
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Guide
Title
Content
§ 255
In 2023 no less than 93% of EU households had internet access. Under these circumstances, and in light of the new Machinery Regulation’s provisions on the format of the instructions, one can consider that respecting those 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.Instructions for use when they are provided in digital format When the instructions for use are provided in digital format, the provisions of Article 10(7) of the new Machinery Regulation can ensure compliance. Compliance with Article 10(7) of that Regulation is appropriate given that the Regulation sets out specific obligations on the manufacturers when they provide the instructions for use in digital format. In addition, in case of machinery for non-professional use made physically available in Member States, it is recommended that the following statement is provided 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 be in a language which can be easily understood by the purchasers in those Member States, as determined by those Member States (see §246). It should be complemented with contact information (postal address and/or telephone) and indicate how those instructions can be requested.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. Based on the risk assessment of the manufacturer, it might be necessary to provide additional information within the safety information that is deemed essential.
§ 261
(...) 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.
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. Compliance with Article 10(8) of that Regulation is appropriate given that the Regulation sets out specific obligations on the manufacturers when they provide EC Declaration of Conformity in digital format.
(...) Assembly instructions, which may be provided in digital format (see §390)
(...)
§ 382
The EC Declaration of Conformity must be typewritten (printed) or handwritten in capital letters.
§ 384
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. When the Declaration of Incorporation is provided in digital format, the provisions of Article 11(8) of the new Machinery Regulation can ensure compliance.
Compliance with Article 11(8) of that Regulation is appropriate given that the Regulation sets out specific obligations on the manufacturers when they provide Declaration of Incorporation in digital format.
§ 390
When the assembly instructions are provided in digital format, the provisions of Article 11(7) of the new Machinery Regulation can ensure compliance. Compliance with Article 11(7) of that Regulation is appropriate given that the Regulation sets out specific obligations on the manufacturers when they provide the assembly instructions for partly completed machinery in digital format. In addition, in case of partly completed machinery made physically available in Member States, it is recommended that the following statement is provided on the packaging, in an accompanying document or on the partly completed machinery itself: ‘The purchaser has the right to request to obtain, free of charge, the assembly instructions in paper format’. This statement should be in a language which can be easily understood by the purchasers in those Member States, as determined by those Member States (see §246). It should be complemented with contact information (postal address and/or telephone) and indicate how those instructions can be requested.
Guides, such as the one discussed here or the guides to other EU directives, play an important role in the interpretation of legal requirements and are valuable sources of knowledge in practice for all persons working with the respective directives and regulations.
Guides do not, however, have the character of law!
You can download the current guide to the Machinery Directive via the following link:
Guide to the application of the Machinery Directive 2006/42/EC, Edition 2.3 - April 2024
Product note
Safexpert 9.1 - The CE software already supports the new Machinery Regulation (EU) 2023/123030
Since version 9.1, Safexpert has been providing you with targeted support when switching to the new Machinery Regulation (EU) 2023/1230. For machines with a long service life that are placed on the market from 20 January 2027, you can now use the CE guide in accordance with the new Machinery Regulation!
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Posted on: 2024-05-15
Daniel Zacek-Gebele, MSc Produktmanager bei IBF für Zusatzprodukte sowie Datenmanager für die Aktualisierung der Normendaten am Safexpert Live Server. Studium der Wirtschaftswissenschaften in Passau (BSc) und Stuttgart (MSc) im Schwerpunkt International Business and Economics.
E-Mail: daniel.zacek-gebele@ibf-solutions.com | www.ibf-solutions.com
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