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      • Round 1
        • Item 0: Background & Action Plan
        • Item 1: CER Update Frequency
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            • 00 Front matter, introduction, writing tips
            • 1. Administrative particulars
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            • 3. Scope of the clinical evaluation
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            • 5. Common specifications and harmonised standards
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  • 5. Common specifications and harmonised standards

5. Common specifications and harmonised standards

Source: CER Template.pdf page 14 (document: Mantra Systems Free CER Template, Edition 2)

List any common specifications and/or harmonised standards that are relevant to the clinical evaluation of the subject device. Assess whether these standards have been complied with - state whether not complied with, partially complied with, or fully complied with.

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4. Clinical evaluation plan — Summary
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6. Clinical background, current knowledge, state of the art
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