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IVDR Device Classification

Use this IVDR Classification Document template to systematically determine and justify the classification of your in vitro diagnostic medical device under EU IVDR 2017/746 Annex VIII rules. Completing this template is essential during the early stages of device development and regulatory submission, as it ensures accurate device classification, which directly impacts conformity assessment routes and regulatory requirements.

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IVDR Classification Document

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Device Classification

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Device Classification Justification

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Annex I: IVDR Annex 2017/746 Annex VIII Classification Rules

Mapping of Requirements

In Vitro Device Regulation (IVDR) 2017/746Document SectionAnnex VIII(All)