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IVDR Classification Toolkit: EU IVDR 2017/746 Risk Class Determination

IVDR Classification Toolkit — Annex VIII rules guide, risk class worksheet, intended purpose template, technical justification memo, NB notification checklist, and IVDD-to-IVDR transition gap analysis.

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What's Included

EU IVDR Classification Rules Application Guide (Annex VIII)
IVDR Risk Class Determination Worksheet
Intended Purpose Statement Template (IVDR)
Classification Technical Justification Memo
Notified Body and Competent Authority Notification Checklist
IVDR Transition and Legacy Device Gap Analysis Template

Benefits

All 7 IVDR Annex VIII classification rules with decision trees and worked examples
Intended purpose template ties directly to classification, performance, and labeling
Classification justification memo structured for notified body technical file review
Legacy device gap analysis covers the IVDD-to-IVDR transition impact assessment

Is This For You?

This toolkit is designed for teams facing these challenges:

IVDR reclassified device upward without formal documentation
Notified body querying classification rationale during technical file review
Intended purpose statement missing required elements under IVDR
IVDD-to-IVDR transition impact not formally assessed

Who This Is For

RA managers responsible for IVDR classification determinationsIVD manufacturers transitioning legacy devices from IVDD to IVDRRegulatory consultants supporting EU market access for IVD devicesQA directors updating technical files for IVDR compliance

Frequently Asked Questions

How is IVDR classification different from IVDD?

IVDD used a simplified list-based system. IVDR uses 7 rules based on intended purpose and public health risk. Most Class I self-test devices under IVDD are now Class C or D under IVDR, requiring notified body involvement.

When does IVDR fully apply?

EU IVDR became fully applicable May 26, 2022. Transition provisions allow legacy IVDD-certified devices until 2025-2027 depending on class, but new devices require full IVDR compliance now.

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Download immediately after purchase. All templates are editable Word and Excel files.

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