IVDR Classification & Conformity Assessment

Under IVDR, over 85% of all in vitro diagnostic assays require Notified Body certification. We establish the exact reasoning chain from analyte, specimen and intended purpose to Annex VIII classification rules and evidence burden.

Define Your IVDR Regulatory Pathway

IVDR Classification Strategy Scope

Intended purpose, target analyte / biological marker and specimen type review

Target clinical population, user environment and medical decision context

Application of IVDR Annex VIII Rules 1–7 across all assay components

Application of the strictest rule where multiple intended purposes or rules apply

Companion diagnostic (CDx) classification and medicinal product co-development strategy

Near-patient testing (NPT) and self-testing regulatory scrutiny and usability impacts

Software qualification (standalone vs accessory) and IVD algorithm classification

Class A (sterile vs non-sterile), Class B, Class C and Class D conformity assessment selection

Notified Body designation code matching and review capacity planning

Performance evaluation depth and ongoing post-market obligations driven by class

Senior-Expert Differentiator

Harmonized Logic from Rule to PER & Labeling

We assess not only the rule outcome, but the exact reasoning chain from intended purpose to classification and then to the evidence burden. That rationale remains rock-solid in the technical documentation, PER, labeling and EUDAMED registration data.

IVDR Risk Class Summary

Class A: General lab products & instruments (Self-declaration unless sterile)

Class B: General IVDs & self-tests without critical risk

Class C: Infectious agents, cancer markers, prenatal & CDx

Class D: High-risk blood screening, life-threatening pathogens (EURL scope)

Classify Your IVD Assay

Establish defensible IVDR classification rationales before commissioning expensive laboratory studies.

Classify Your Assay

Establish an Unshakeable IVDR Classification & Conformity Strategy

Our IVD specialists analyze your assay markers, clinical claims, and risk class under Regulation (EU) 2017/746.

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