Introduction: When Study Completion Isn’t the Finish Line
For many IVD manufacturers, completing a performance study feels like crossing a major regulatory milestone.
Budgets are spent. Timelines are met. Internal teams move on to the next priority.
Yet during IVDR conformity assessment, Notified Bodies frequently raise new questions sometimes requesting additional data, re-analysis, or even entirely new studies.
This leaves manufacturers asking a difficult but increasingly common question:
If the performance study is completed, why is it still being challenged?
Under IVDR, the answer rarely lies in execution quality. Instead, it lies in how the study was designed, positioned, and aligned with regulatory expectations from the start.
Completion Is No Longer the Same as Regulatory Acceptance
https://eur-lex.europa.eu/eli/reg_impl/2022/1107/oj
Under IVDR, performance studies are not evaluated based on effort, cost, or completion status.
They are evaluated based on whether they:
- Clearly support the intended purpose
- Defensibly demonstrate performance claims
- Reduce regulatory uncertainty for reviewers
A study can be scientifically sound and operationally well executed yet still fail to meet these criteria.
This represents a fundamental shift from pre-IVDR expectations that many manufacturers underestimate.
Where the Real Regulatory Risk Is Introduced
Most manufacturers assume regulatory risk arises during Notified Body review.
In reality, the highest risk is introduced much earlier at the study design stage.
IVDR performance studies are frequently challenged because:
- Endpoints do not clearly map to stated performance claims
- Study populations are not sufficiently justified for the intended use
- Acceptance criteria lack clear clinical or regulatory relevance
- Generated data cannot be directly integrated into the Performance Evaluation Report (PER)
Once a study is completed, these gaps are difficult and expensive to correct.
The Business Impact of a Questioned Performance Study
When a completed IVDR performance study is challenged, the consequences are rarely minor.
Manufacturers may face:
- Requests for additional or supplementary studies
- Re-analysis of existing datasets
- Extended conformity assessment timelines
- Budget overruns not planned during initial study design
- Delays in market access or product launches
At this stage, corrective actions cost significantly more than early regulatory alignment would have.
What Regulators Are Actually Evaluating Under IVDR
Under IVDR, reviewers are asking practical, outcome-focused questions such as:
- Does this study clearly support the stated intended purpose?
- Are performance claims appropriately demonstrated?
- Is the data suitable for regulatory decision-making?
- Does the study reduce uncertainty or create new questions?
If these questions are not answered clearly, study completion becomes secondary.
Why CRO Involvement Has Become a Strategic Business Decision
Traditionally, CROs were engaged primarily to execute studies.
Under IVDR, CRO involvement increasingly serves a different purpose:
regulatory risk management.
For manufacturers, the value of a CRO now lies in ensuring that:
- Study design aligns with IVDR expectations
- Evidence generated is regulator-ready
- Data can be directly used in performance evaluation and technical documentation
- Downstream regulatory objections are minimized
This shift is especially important for manufacturers with limited internal clinical or regulatory bandwidth.
IVDR Performance Studies as Risk-Control Tools
Under IVDR, performance studies are no longer technical checkboxes.
They are commercial risk-control tools that directly influence:
- Regulatory timelines
- Market access
- Return on investment
Manufacturers who treat performance studies as part of a broader regulatory strategy—rather than isolated technical tasks—are far better positioned to navigate IVDR scrutiny with confidence.
Final Thoughts: The Question That Really Matters
The critical IVDR question is no longer:
“Have we completed the performance study?”
It is:
“Does this study genuinely stand up to regulatory review and reduce uncertainty?”
Manufacturers who address this question early avoid costly surprises later.
Those who do not often discover the gap only when timelines and budgets are already under pressure.
How Bioexcel Supports IVDR-Aligned Performance Studies
https://bioexcelife.com/consulting-services/
Bioexcel operates as a medical device Clinical Research Organization (CRO) with a strong focus on regulatory-aligned clinical evidence generation.
We support IVD manufacturers by:
- Designing IVDR-aligned performance studies
- Ensuring evidence usability for regulatory submissions
- Reducing downstream regulatory risk through early alignment
Our approach focuses on defensibility not just execution.
