Comparison of Legal Requirements: The Machinery Directive vs. the Machinery Regulation
1.7.4.1. General principles for the drafting of instructions (of instructions for use)
Changes
Language and translation requirements are removed from this section and addressed elsewhere in the Regulation.
- Requirement removed: "The instructions for use shall be drafted in one or more of the official languages of the Community..."
- Requirement removed: "The designation ‘Original instructions for use’ shall be indicated..."
- Requirement removed: requirement for translation and marking "Translation of the original instructions for use"
- Requirement modified: language requirements and marking are moved out of this section
- The scope is expanded to include related products
Proposed measures
- Ensure that language requirements for the instructions for use are not verified solely against point 1.7.4.1, but also against Article 10.7
- Update internal requirement specifications and templates so that language and translation requirements are no longer expected to be found in this point
- Verify that requirements for “Instructions for use in the original language” and marking of translations are handled in accordance with Article 10.7
- Check that no incorrect conclusion has been drawn that language requirements have been removed from the legislation
- Ensure that the content of the instructions for use covers:
intended use
reasonably foreseeable misuse
- Verify that the instructions for use are adapted to the user’s level of knowledge, especially for:
non-professional users
operators without specialist competence
- Ensure that internal guidelines for technical documentation include requirements to describe misuse (not only intended use)
- Check that the risk assessment is linked to:
instructions in the instructions for use
both correct use and misuse
- Update documentation and processes so that the concept of “machine” also encompasses “related product” where applicable
- Ensure that training materials and user instructions are designed with consideration of:
the actual level of competence and understanding of the target audience
Machinery Directive statutory text
1.7.4.1. General principles for the drafting of instructions
(a) The instructions must be drafted in one or more official Community languages. The words ‘Original instructions’ must appear on the language version(s) verified by the manufacturer or his authorised representative.
(b) Where no ‘Original instructions’ exist in the official language(s) of the country where the machinery is to be used, a translation into that/those language(s) must be provided by the manufacturer or his authorised representative or by the person bringing the machinery into the language area in question. The translations must bear the words ‘Translation of the original instructions’.
(c) The contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereof.
(d) In the case of machinery intended for use by non-professional operators, the wording and layout of the instructions for use must take into account the level of general education and acumen that can reasonably be expected from such operators.
Read more
Machinery Regulation legal text
1.7.4.1. General principles for the drafting of instructions for use
(a) The contents of the instructions for use shall cover not only the intended use of the machinery or related product but also take into account any reasonably foreseeable misuse thereof;
(b) In the case of machinery or related products intended for use by non-professional operators, the wording and layout of the instructions for use shall take into account the level of general education and acumen that can reasonably be expected from such operators.
Read more
Har du några frågor? Kontakta oss