IVDR Classification & Risk Class Toolkit
EU IVDR reclassified most IVD devices upward. Document your classification determination with templates built for notified body review.
What You Get
EU IVDR Classification Rules Application Guide (Annex VIII)
Complete walkthrough of the 7 EU IVDR 2017/746 classification rules with decision trees for each rule. Covers the fundamental change from IVDD risk classes to IVDR A/B/C/D classification, the companion diagnostic uplift rule, and the near-patient testing rules that reclassified thousands of legacy devices. Includes worked examples for immunoassays, molecular diagnostics, point-of-care tests, and companion diagnostics.
IVDR Risk Class Determination Worksheet
Structured worksheet for documenting your device's IVDR risk class determination. Covers rule-by-rule analysis, intended purpose statement alignment, list A and List B annexes, performance evaluation evidence requirements by class, and the impact of class on conformity assessment route (Annex IX, X, XI). Designed as a controlled QMS document.
Intended Purpose Statement Template (IVDR)
Template for drafting an IVDR-compliant intended purpose statement covering all required elements: analyte or marker, specimen type, patient population, intended user, intended use environment, and clinical purpose. Includes guidance on how the intended purpose drives classification, performance requirements, and labeling obligations.
Classification Technical Justification Memo
Formal memo template for documenting and defending your IVDR classification decision to notified bodies, competent authorities, and internal stakeholders. Covers rule analysis rationale, comparator device justification, borderline device argumentation, and the documentation standard notified bodies expect during technical file review.
Notified Body and Competent Authority Notification Checklist
Complete checklist for Class C and D IVDR devices requiring notified body involvement. Covers NB selection criteria, application package requirements, consultation obligations for companion diagnostics, competent authority notification triggers, and the EUDAMED registration requirements that apply before CE marking.
IVDR Transition and Legacy Device Gap Analysis Template
Structured gap analysis for medical laboratories and manufacturers transitioning legacy IVD devices from IVDD to IVDR. Covers classification change impact, new performance evaluation requirements, technical documentation gaps, QMS update obligations, and the transition timeline milestones under EU IVDR Article 110.
Why It Works
All 7 IVDR classification rules covered
The classification guide walks through every Annex VIII rule with decision trees — including the companion diagnostic uplift rule that catches most manufacturers off guard.
Intended purpose drives everything
The intended purpose template is structured so every element ties directly to classification, performance requirements, and labeling — one document that anchors your entire technical file.
Built for transition and legacy devices
The IVDD-to-IVDR gap analysis template addresses the most common situation: manufacturers with legacy devices that need classification redetermination before the transition deadline.
From the Field
"IVDR reclassified most of what was Class I self-test under IVDD into Class C or D. If your legal manufacturer has not done a formal classification determination under the new rules, you are operating on borrowed time. This toolkit makes the analysis defensible."
"The classification rules application guide saved us weeks of notified body back-and-forth. Having the worked examples for companion diagnostics and near-patient testing in one place is worth the price alone."
FAQ
How is IVDR classification different from IVDD?
IVDD classified devices into a simplified list-based system. IVDR uses 7 rules based on intended purpose, risk to individual and public health, and analyte type. Most devices that were Class I self-test under IVDD are now Class C or D under IVDR, requiring notified body involvement.
When does IVDR fully apply?
EU IVDR 2017/746 became fully applicable on May 26, 2022. Transition provisions under Article 110 allow legacy IVDD-certified devices to remain on the market until 2025-2027 depending on class, but new devices and renewals require full IVDR compliance.
What format are the documents?
All documents are editable Word and Excel templates ready for direct use in your technical documentation file.
Ready to get started?
6 templates. Instant access. Built for EU IVDR compliance.
This website and all content are for informational purposes only. Not legal or regulatory advice. Legal