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Highest-Risk IVDR Scrutiny

Class D IVD Strategy, EURL & Higher-Risk Scrutiny

Class D IVDs (blood screening assays, life-threatening infectious pathogens) undergo the highest regulatory scrutiny in Europe. We sequence analytical and clinical evidence generation, Common Specifications, Notified Body review and designated EURL verification.

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Class D Strategy Considerations

Rule 1 / Rule 2 / applicable Class D classification rationale & claim boundaries
Notified Body Annex IX or Annex X/XI high-risk conformity assessment planning
Performance evaluation depth and robust clinical specimen bank evidence
Compliance with European Common Specifications (CS) (Commission Implementing Regulation (EU) 2022/1107) where applicable
EU Reference Laboratory (EURL) involvement where the device falls within a designated EURL scope and the relevant procedure applies
Performance verification testing by designated EURL laboratories where applicable
Batch testing / verification procedures and release protocol implications where applicable
Certified reference materials, reference measurement procedures and lot consistency
High-risk change-control impact assessments and mandatory Notified Body notifications
Annual PMPF evaluation report authoring and annual PSUR submissions
Project timeline sequencing accounting for concurrent Notified Body and EURL reviews

Key Questions for Senior Regulatory Review

1Is the Class D classification rationale robust and aligned with the exact intended purpose?
2Does a current European Common Specification (CS) apply to the target analyte?
3Does the device fall within the scope of an operational EU Reference Laboratory (EURL)?
4Are study materials, multiple lots and reference methods suitable for highest-tier scrutiny?
5Does the regulatory project plan allow for EURL / NB interaction and batch testing logistics?
NKB Planning Approach

Early Sequencing Prevents Late Surprises

For Class D IVDs, we map the regulatory pathway early so that analytical and clinical evidence generation, Common Specifications compliance, Notified Body review and any applicable EURL interface are carefully sequenced rather than discovered late in the development program.

Class D Regulatory Elements

• Common Specifications: Mandatory analytical & diagnostic thresholds

• EURL Verification: Verification of performance claims where applicable

• Batch Verification: Control of manufactured lots where required

• Annual PSUR & PMPF: Strict yearly lifecycle reporting

Class D Assessment

Map your Class D IVDR timeline, Common Specifications, and EURL verification requirements.

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Master Class D IVDR Compliance with Seasoned Regulatory Leadership

Our high-risk IVD consultants guide manufacturers through Common Specifications, Notified Bodies, and EURLs.

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