User instruction
Explanation of the requirements regarding user instructions and manuals.
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Introduction
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Step 1 - Determine applicable regulations & standards
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Step 2 - Conformity Assessment
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Step 3 - User instruction, product label and product packaging
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Step 4 - Proof of compliance: Building your 'Product Files'
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Step 5 - Declaration of Conformity and conformity marking
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Step 6 - Continual Compliance