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CE requirements for User Manuals

Where to find the CE requirements for an User Manual?

Date: 14.02.2017 (from Certification Company)

Answer:

Getting the CE mark is a complex procedure with lots of requirements regarding health, security, environment and consumer protection. The User Manual also plays an important 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.

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 should be included to the User Manual. If neither Directive, nor harmonised standard contains requirements, then IEC 82079-1 – Preparation of instructions for use – General principles and detailed requirements should be considered.

Do you hesitate about the format of your User Manuals or do you want to know the specific requirements for your product?
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