Subtract to Ship: MDR Playbook · Chapter 6 Worksheet
Device Classification & Conformity Assessment Procedure
From Chapter 6: Classification (Getting Your Product Class Right)
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What this worksheet does
Walk through every classification rule in MDR Annex VIII systematically, with your intended purpose from Chapter 5 in hand. Do not skip rules that seem irrelevant: the strictest applicable rule wins.
Time to complete: Two hours, with the current MDR Annex VIII open
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