Regulatory

EU IVDR Compliance

Regulation (EU) 2017/746 — risk-based class A/B/C/D pathway.

Representative work

Device classes & artefacts we support.

IVD Genomics Array
IVD Genomics Array
IVD Analyzer
IVD Analyzer
Diagnostic instrumentation
Diagnostic instrumentation
IVD Covid testing kit
IVD Covid testing kit

The problem

IVDR reclassified ~85% of legacy IVDs into higher risk classes — most now need a Notified Body and Performance Evaluation Report and Post Market Performance Follow up Report

Our solution

Risk-based IVDR program: classification, Performance Evaluation, Scientific Validity, Analytical & Clinical Performance.

Process

How we run this engagement.

  1. IVDR classification rules application

  2. PER authoring

  3. Performance studies design (analytical & clinical)

  4. Notified Body selection (Class B, C, D)

  5. PMPF plan & reporting

Regulation (EU) 2017/746 — risk-based class A/B/C/D pathway.

How we help

Risk-based IVDR program: classification, Performance Evaluation, Scientific Validity, Analytical & Clinical Performance.

Category

EU Regulatory

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