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Instruction-manual compliance review

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The following sections describe the document in general terms, from published Union law. They are not a list of deliverables of the priced review.

What the document is

Instructions tell the user how to install, use, maintain and, where relevant, dismantle the product without being exposed to risks that the instructions are meant to explain. For machinery, Directive 2006/42/EC, Annex I, section 1.7.4, requires instructions in the official Community language or languages of the Member State in which the machinery is placed on the market or put into service.

The instructions are either original instructions or a translation of the original instructions. A translation is accompanied by the original. For consumer products, Regulation (EU) 2023/988, Article 9(7), requires clear instructions and safety information in a language easily understood by consumers, as determined by the Member State in which the product is made available, unless the product can be used safely and as intended without them.

Role and who is responsible

The manufacturer is responsible for the instructions. The words “Original instructions” appear on the language version or versions verified by the manufacturer or the authorised representative. Where no original exists in the official language of the country of use, a translation is supplied by the manufacturer or the authorised representative, or by the person bringing the machinery into that language area, and it bears the words “Translation of the original instructions”.

Maintenance instructions intended for specialised personnel mandated by the manufacturer may, by exception, be supplied in one Community language that those personnel understand.

Elements typically expected

Where applicable, section 1.7.4.2 of Annex I to Directive 2006/42/EC asks each instruction manual to contain at least the following.

  • The business name and full address of the manufacturer and of the authorised representative.
  • The designation of the machinery as marked on it, without requiring the serial number in the manual.
  • The EC declaration of conformity, or a document setting out its contents.
  • A general description, and the drawings and explanations needed for use, maintenance, repair and checking correct functioning.
  • The intended use, and warnings concerning ways in which the machinery must not be used that experience has shown might occur.
  • Assembly, installation and connection instructions, and information on residual risks.

Frequent gaps

These are general patterns, not a finding about a particular manual.

  • There is no language version for the Member State of placing on the market or putting into service.
  • A translation is not identified as a translation of the original instructions, or the original does not accompany it.
  • Intended use is stated, but foreseeable misuse is not.
  • Residual risks that remain after the protective measures are not mentioned.
  • Instructions for the user and instructions reserved for mandated specialist personnel are not distinguished.

Questions to prepare

  • In which Member States will the machinery or product be placed on the market or put into service?
  • Is the text the original, a translation, or both, and which version did the manufacturer verify?
  • Is the operator a professional or a non-professional?
  • Which tasks must the text cover: transport, installation, use, cleaning, maintenance, dismantling?
  • Which version of the product does the text describe?

Regulatory limits

Instructions do not replace the technical file or the declaration of conformity. Wording in a manual does not remove a design duty where the essential requirements require the risk to be eliminated or reduced by design.

The language rule depends on the act and the Member State. Section 1.7.4 of the Machinery Directive is the machinery rule. Article 9(7) of Regulation (EU) 2023/988 is the consumer-product rule, and it does not apply where the product can be used safely and as intended without instructions. The obligations depend on the product and on the applicable act. The rules of the Machinery Directive, the Low Voltage Directive 2014/35/EU and the Radio Equipment Directive 2014/53/EU, including CE marking where the applicable text provides for it, are separate from Regulation (EU) 2023/988. There is no CE marking under that Regulation.

Legal basis. Directive 2006/42/EC, Annex I, sections 1.7.4, 1.7.4.1 and 1.7.4.2; Regulation (EU) 2023/988, Article 9(7).

Starting price

from €490

Displayed prices are for initial guidance. The final scope and project fee are quoted individually after the product review and initial consultation.
All prices are starting prices, excluding VAT where applicable. Services are offered exclusively to business customers. The binding project fee and scope are agreed in writing.

Scope

  • The exact product and document scope is agreed before work starts.
  • Work already included in your full package is not charged again.
  • Standalone document reviews do not constitute a full product conformity assessment.
  • The statutory responsibility of the manufacturer and other relevant economic operators remains unaffected. No appointment as authorised representative, importer, responsible person or other economic operator arises unless separately assessed and expressly agreed.

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