Bioexcelife
For many medical device teams, CER is a familiar term. But for IVD manufacturers under the EU IVDR, the focus shifts from a Clinical Evaluation Report (CER) to a Performance Evaluation Report (PER).
This is not just a change in wording.
It reflects a major shift in how evidence must be planned, collected, reviewed, and maintained for in vitro diagnostic devices. Under the IVDR, manufacturers must show that their IVD performs as intended and provides reliable results in the right clinical context.
Why the difference matters
A CER is mainly used for medical devices under the MDR. It focuses on clinical safety, clinical performance, and benefit-risk evaluation.
A PER, on the other hand, is specific to IVDs under IVDR. It focuses on whether the test delivers reliable performance. This includes scientific validity, analytical performance, and clinical performance.
So, while both documents support regulatory approval, they answer different questions.
A CER asks:
Is the device clinically safe and effective?
A PER asks:
Does the IVD test accurately and reliably measure what it claims to measure?
That difference matters because IVDs do not act on the body in the same way many medical devices do. Their value comes from the quality and reliability of the information they provide.
What changes under IVDR?
Under IVDR, performance evaluation is not a one-time task. It is a continuous process that must remain updated throughout the device lifecycle. The European Commission’s MDCG guidance includes documents for IVDR performance evaluation and performance studies, including MDCG 2022-2 and MDCG 2025-5.
This means IVD manufacturers need stronger evidence planning from the beginning. The performance evaluation must connect with risk management, post-market performance follow-up, and technical documentation.
In simple terms, your PER must tell a clear evidence story.
The three pillars of PER
A strong PER is built on three key areas.
First, scientific validity shows the link between the analyte and the clinical condition or physiological state. For example, it explains why a biomarker is meaningful for a specific diagnosis or medical decision.
Second, analytical performance shows how well the test measures the analyte. This may include accuracy, precision, sensitivity, specificity, repeatability, reproducibility, and limits of detection.
Third, clinical performance shows how well the test result relates to the clinical condition or intended purpose in the target population.
Together, these three elements create the foundation of IVD performance evidence.
Why PER preparation is more demanding
Many manufacturers underestimate the depth required for a PER.
Under IVDR, it is not enough to say the test works. You must prove it with structured evidence. You must also show that the evidence matches the intended purpose, risk class, user group, and clinical setting.
This becomes especially important for higher-risk IVDs, novel assays, companion diagnostics, and devices with limited historical evidence.
Also, if performance data is weak, outdated, or poorly linked to claims, Notified Bodies may raise questions. This can delay certification and increase rework.
Common gaps IVD manufacturers face
One common gap is weak linkage between claims and evidence. The intended purpose may say one thing, but the performance data may not fully support it.
Another issue is outdated literature. A PER must reflect current scientific and clinical knowledge.
Manufacturers also face problems when analytical performance data is strong, but clinical performance evidence is limited. Under IVDR, both matter.
Finally, many PERs fail to connect properly with PMPF. Post-Market Performance Follow-up is essential because it confirms whether the IVD continues to perform as expected after market placement.
PER is a living document
A strong PER does not end at CE marking.
After market entry, manufacturers must use PMS and PMPF data to keep performance evaluation current. If new risks, trends, complaints, or performance concerns appear, the PER should reflect them.
This lifecycle approach is one of the biggest differences under IVDR.
The goal is not just approval. The goal is continued confidence in the test’s performance.
What IVD manufacturers should do now
IVD manufacturers should review their current evidence strategy and check whether it is truly IVDR-ready.
The first step is to confirm that the intended purpose is clear and supported. Then review whether scientific validity, analytical performance, and clinical performance are complete and well connected.
Next, check whether PMPF activities are meaningful and linked back to the PER.
This helps build a stronger technical file and reduces the chance of Notified Body questions.
Final thoughts
PER and CER may sound similar, but they are not the same.
For IVD manufacturers, the shift from CER thinking to PER thinking is critical. IVDR expects a performance-based, evidence-driven, and lifecycle-focused approach.
A strong PER does more than support compliance. It builds confidence in the test, supports market access, and protects patient safety.
How Bioexcel can help
At Bioexcel, we support IVD manufacturers with IVDR performance evaluation, PER preparation, PMPF strategy, evidence gap assessment, and technical documentation alignment.
We help you build a PER that is clear, complete, and ready for regulatory review.
Need support with PER under IVDR? Partner with Bioexcel for a stronger and smoother compliance journey.
