Comparison of Legal Requirements: The Machinery Directive vs. the Machinery Regulation
1.7.4. Instructions (for use)
Changes
The requirements are moved from this point to Article 10.7 and restructured.
- Requirement removed: “All machinery shall be accompanied by instructions for use in the official language or languages of the Member State in which the machinery is placed on the market and/or put into service.”
- Requirement removed: “The accompanying instructions for use shall be either ‘Original instructions for use’ or ‘Translation of the original instructions for use’. Where a translation of the instructions for use is provided, the ‘Original instructions for use’ shall accompany it.”
- New requirement: “In addition to the obligations set out in Article 10.7, the instructions for use shall be drawn up in the manner specified below.”
- Requirement amended: language requirements moved to a reference in Article 10.7
- Requirement amended: “his authorised representative” replaced by “the manufacturer’s representative”
Article 10.7 in full:
7. Manufacturers shall ensure that the machinery or the related product is accompanied by instructions for use and information in accordance with Annex III. The instructions for use may be provided in digital format. Such instructions for use and such information shall clearly describe the product model to which they relate.
When the instructions for use are provided in digital format, the manufacturer shall
a) indicate on the machinery or the related product or, if this is not possible, on the packaging or in an accompanying document how to access the digital instructions for use,
b) present them in a format that allows the user to print and download them and save them on an electronic device so that they are always accessible, in particular in the event of a malfunction of the machinery or the related product; this
requirement also applies where the instructions for use are embedded in the software of the machinery or the related product,
c) make them available online for the expected lifetime of the machinery or the related product and for at least ten years after the machinery or the related product has been placed on the market.
At the time of purchase, however, the manufacturer shall, at the user’s request, provide the instructions for use free of charge in paper form within one month.
In the case of machinery or a related product intended for non-professional users, or which, under reasonably foreseeable conditions, may be used by non-professional users even if it is not intended for them,
the manufacturer shall provide, in paper form, the safety information necessary for the machinery or related product to be put into service and used safely.
The instructions for use, the safety information and the information referred to in Annex III shall be clear, understandable and legible and provided in a language easily understood by users and determined by the Member State concerned.
Proposed measures
- Ensure that requirements for the instruction manual are not verified solely against Annex III, point 1.7.4, but also against Article 10.7
- Update internal checklists and processes so that Article 10.7 is referenced for instruction manual requirements
- Verify that language requirements for the instruction manual are met in accordance with Article 10.7 and have not been omitted due to the restructuring
- Ensure that requirements for the “original instruction manual” and translations are handled correctly in accordance with Article 10.7
- Check that the instruction manual is linked to the correct machine model and version (traceability)
- Establish or verify a process for the digital instruction manual, including:
download
printing
storage
- Ensure that access to the digital instruction manual is indicated on:
the machine
packaging
or accompanying documents
- Verify that the digital instruction manual is available:
for the entire lifetime
for at least 10 years after being placed on the market
- Ensure that there is a process for providing a paper copy:
upon request
within 1 month
free of charge
- Check that the instruction manual contains what is required under 1.7.4.2
- Ensure that safety information for non-professional users is provided in paper format (where applicable)
- Verify that exceptions for maintenance instructions for specialized personnel are handled correctly with regard to the intended audience and the correct language
- Check that internal documents (e.g. specifications, templates, training materials) do not refer only to the Annex but also include Article 10.7
Machinery Directive statutory text
1.7.4. Instructions
All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service.
The instructions accompanying the machinery must be either ‘Original instructions’ or a ‘Translation of the original instructions’, in which case the translation must be accompanied by the original instructions.
By way of exception, the maintenance instructions intended for use by specialised personnel mandated by the manufacturer or his authorised representative may be supplied in only one Community language which the specialised personnel understand.
The instructions must be drafted in accordance with the principles set out below.
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Machinery Regulation legal text
1.7.4. Instructions for use
In addition to the obligations set out in Article 10(7), instructions for use shall be drawn up as set out below.
By way of exception to Article 10(7), the maintenance instructions intended for use by specialised personnel mandated by the manufacturer or its authorised representative may be supplied in only one official language of the Union which the specialised personnel understand.
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