Introduction: Why Performance Evaluation Is Where IVDR Decisions Are Made
Many IVD manufacturers assume that once performance studies are completed, regulatory approval is largely procedural.
Under IVDR, this assumption is risky.
In practice, Notified Bodies make their most critical decisions during performance evaluation review. This is where scientific validity, analytical performance, and clinical performance are judged not in isolation, but as a coherent regulatory argument.
Understanding what Notified Bodies really assess and how they assess it is essential to avoiding delays, additional data requests, or failed conformity assessments.
What Is Performance Evaluation Under IVDR?
The IVDR Definition (High Level)
Under IVDR, performance evaluation is the continuous process of assessing and analyzing data to demonstrate that an IVD achieves its intended purpose and performs as claimed.
Performance evaluation rests on three mandatory pillars:
- Scientific validity
- Analytical performance
- Clinical performance
These are documented collectively in the Performance Evaluation Report (PER).
What Notified Bodies Are Actually Looking For
Notified Bodies do not assess performance evaluation as a checklist exercise.
They assess whether the entire evidence package reduces regulatory uncertainty.
At a high level, reviewers ask:
- Does the evidence clearly support the intended purpose?
- Are performance claims defensible?
- Is the evidence internally consistent?
- Can regulatory decisions be made confidently using this data?
If the answer to any of these is unclear, questions follow regardless of how many studies were completed.
Pillar 1: Scientific Validity The Starting Point
What Notified Bodies Assess
Scientific validity establishes whether the analyte, marker, or parameter being measured is clinically meaningful for the stated intended purpose.
Notified Bodies look for:
- Clear linkage between the analyte and the clinical condition
- Robust literature or guideline support
- Justification that the biological rationale is accepted
Common Issues Seen
- Weak or outdated literature
- Overreliance on internal rationale
- Poor alignment between scientific validity and claimed clinical utility
Without solid scientific validity, downstream performance data carries less weight.
Pillar 2: Analytical Performance More Than Just Test Results
Analytical performance is often where manufacturers feel most confident.
Yet this is also where misalignment frequently appears.
What Notified Bodies Assess
- Are analytical studies appropriate for the intended use?
- Are performance characteristics (e.g., sensitivity, specificity, precision) relevant and justified?
- Are acceptance criteria clinically and statistically defensible?
Common Issues Seen
- Acceptance criteria chosen without clinical justification
- Studies conducted correctly but designed without regulatory context
- Results that cannot be clearly linked to performance claims
Good data alone is not enough regulatory relevance matters.
Pillar 3: Clinical Performance The Highest Scrutiny Area
Clinical performance is often where IVDR reviews slow down.
What Notified Bodies Assess
- Does the clinical evidence demonstrate performance in the target population?
- Are study populations representative of intended users and settings?
- Can results be generalized to real-world use?
Common Issues Seen
- Study populations not aligned with intended use
- Endpoints that do not directly support claims
- Difficulty integrating study data into the PER narrative
This is where many completed performance studies still fail to satisfy reviewers.
The Performance Evaluation Report (PER): Where Everything Must Connect
The PER is not a compilation of documents.
It is a regulatory argument.
Notified Bodies assess whether:
- Scientific validity, analytical performance, and clinical performance are coherent
- Conclusions are supported by data not assumptions
- Gaps are identified and justified
- Residual uncertainty is acknowledged and controlled
A weak PER structure can undermine otherwise strong data.
Why Many Performance Evaluations Are Challenged
Across IVDR reviews, recurring issues include:
- Disconnected evidence across the three pillars
- Overconfidence in completed studies
- Lack of clear justification for design choices
- Poor traceability between claims, data, and conclusions
In most cases, the problem is not insufficient effort, but insufficient regulatory positioning.
How Manufacturers Can Reduce Notified Body Pushback
Successful IVDR performance evaluations typically share common traits:
- Early alignment between intended purpose and evidence strategy
- Performance studies designed with PER integration in mind
- Clear justification of endpoints, populations, and acceptance criteria
- Transparent handling of limitations and residual risks
Performance evaluation must be planned as a strategic regulatory activity, not a downstream documentation task.
Final Takeaway: What Notified Bodies Really Assess
Under IVDR, Notified Bodies are not asking:
“Did you complete performance studies?”
They are asking:
“Does this performance evaluation convincingly support regulatory decision-making?”
Manufacturers who understand this distinction and plan accordingly navigate IVDR conformity assessment with far fewer surprises.
