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Where to find the CE requirements for a User Manual?

04.12.2015

Obtaining the CE marking is a complex procedure with lots of requirements regarding health, security, environment, and consumer protection. The User Manual also plays a significant role within the CE mark requirements.

Depending on the product, certain Directive(s) should be considered. For machinery and installations, User Manual requirements are mentioned in the Machinery Directive 2006/42/EC under Annex I, paragraph 1.7.4.2 (contents of the manual). The Personal Protective Equipment (PPE) Directive (Annex I, paragraph, 1.4) and the Medical Devices Directive (Annex I, paragraph, 13.6) also contain mandatory requirements for User Manuals. It is the responsibility of an economic operator (usually the manufacturer) to verify if CE marking Directive(s) relevant to its product contain mandatory requirements for a User Manual.

Please note: If a Directive does not contain any requirements for a User Manual, the economic operator can look into the relevant harmonised product standards. These often include additional requirements on the information that the User Manual should also contain. If neither Directive nor harmonised standard encloses requirements, then IEC 82079-1 – Preparation of instructions for use – General principles and detailed requirements should be considered.

Do you have any questions about the format of your User Manuals, or would you like to know more about the specific requirements for your product?

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