Case studyIVD

IVDR Certification for Class C and Class D IVDs: Complete Annex II/III Documentation

Manufacturer of in-vitro diagnostics in risk classes C and D

An IVD manufacturer faced critical IVDR deadlines for its Class D products, with limited internal capacity for the extensive regulatory, clinical and analytical requirements and insufficient evidence for the conformity assessment.

The challenge

The situation

A manufacturer of in-vitro diagnostics faced critical IVDR deadlines for its Class D products, compounded by limited internal capacity for the extensive regulatory, clinical and analytical requirements. The conformity assessment for both the Class C and Class D products lacked sufficient evidence, requiring an overhaul of the regulatory documentation and structured management of interactions with the Notified Body.

Our approach

What we delivered

Revision of the regulatory documentation, including complete Annex II/III technical documentation for the affected device classes

Structured tracking and management of all Notified Body queries to accelerate the review process

Systematic reconciliation of analytical and clinical evidence to underpin the conformity assessment

The outcome

Results & impact

1 IVDR certification achieved

Certification for Class C and Class D devices achieved within the planned timeframe.

3 device classes addressed

Complete Annex II/III documentation produced for the affected device classes.

0 open Notified Body queries

All Notified Body queries resolved through structured preparation and tracking.

In summary

The manufacturer achieved IVDR certification for its Class C and Class D products with complete Annex II/III documentation and no open Notified Body queries.

Regulations & standards considered

IVDR
IVDR Annex II/III

Related expertise

IVD Consulting & IVDR Readiness →

Classification under Annex VIII, performance evaluation under Art. 56 and support through the notified body

Technical Documentation & UDI →

MDR-compliant technical documentation per Annex II/III, with GSPR checklist and UDI

IVD Performance Studies →

Performance evaluation plan under Annex XIII and evidence of analytical and clinical performance

Health Authority Interaction →

Preparing health authority interactions, plus inspection and CAPA communication

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Sources

Entourage project experience (anonymized)

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