IVD classification (IVDR)
Support with classifying in vitro diagnostic medical devices (IVDs) under the EU IVDR. Correct classification is the starting point for your conformity assessment route, evidence requirements and timelines.
Why IVDR classification matters
- Determines your risk class (A, B, C, D) and whether a Notified Body is involved.
- Sets expectations for performance evaluation, clinical evidence, and quality management.
- Impacts labeling, intended purpose wording, and your technical documentation structure.
- Avoids costly rework later (wrong class often means wrong evidence plan).
IVDR risk classes (overview)
Under IVDR, IVDs are classified into four classes:
Class A
Lowest risk (note: sterile Class A has additional requirements).
Class B
Moderate individual / low public health risk.
Class C
High individual risk and/or moderate public health risk.
Class D
Highest risk (high public health risk).
The exact class follows from the IVDR classification rules applied to your intended purpose, specimen type, target population and the decision impact.
How classification is assessed (practical checklist)
- Intended purpose statement: what condition/analyte you detect, for whom, and for what decision.
- Where results are used: screening, diagnosis, monitoring, prognosis, therapy selection, donor screening, near‑patient use, self‑testing, etc.
- Public health impact: potential harm if results are wrong or delayed.
- Type of specimen: e.g., blood, tissue, saliva; and whether it relates to transmissible agents.
- User and setting: laboratory professional, near‑patient, lay person (self‑test).
- Technology and controls: reagent, calibrator, software, instrument, standalone IVD vs system.
What we deliver
- Classification rationale memo (selected rule(s) and justification).
- Review of intended purpose wording to align with the chosen class.
- Conformity assessment route outline (high level) and key evidence expectations.
- Next‑step plan for performance evaluation and documentation.
Next steps
After classification we typically proceed with:
