IVD Performance Evaluation (PEP and PER)
For an in vitro diagnostic device, performance evaluation is the heart of the technical file and the document set a Notified Body reads most closely. Under the EU IVDR (2017/746), it is built on three pillars, and the conclusions only hold if all three are satisfied. EvySaif prepares the full IVD performance evaluation, from the plan that scopes the evidence to the report that concludes on your intended purpose, grounded in IVDR Annex XIII and EN ISO 20916:2024.
The three pillars of performance evaluation
Performance evaluation stands on three pillars, and a Notified Body reads all three. Each is documented separately, then synthesized into conclusions that support your intended purpose, labeling claims, and CE marking.
Scientific validity
Establishes that the analyte you measure is genuinely associated with the clinical condition or physiological state your device targets, evidenced from peer-reviewed literature, consensus documents, and proof-of-concept data appraised through a structured search, so the association is documented rather than assumed.
Analytical performance
Demonstrates that the device correctly and reliably detects or measures the analyte, the bench-level evidence in IVDR Annex I: trueness and precision, analytical sensitivity and specificity, limit of detection and quantitation, measuring range and linearity, cut-off, and cross-reactivity, interference, and stability, each against defined acceptance criteria.
Clinical performance
Shows the device yields results correlated with the target condition in the intended population and user, using diagnostic sensitivity and specificity, positive and negative predictive values, and likelihood ratios. Where existing data is insufficient under Annex XIII, a dedicated clinical performance study may be required.
Plan, report, and follow up
The Performance Evaluation Plan (PEP) scopes the evidence; the Performance Evaluation Report (PER) synthesizes it into conclusions. The two must stay aligned, and Post-Market Performance Follow-up (PMPF) under Annex XIII Part B keeps it current, revisited at defined intervals for Class C and D.
Where a study is needed: where existing literature and data cannot demonstrate clinical performance, IVDR Annex XIII may require a dedicated clinical performance study. We design that protocol too, feeding it back into the PER.
What we prepare
PEP and PERPerformance Evaluation Plan and Performance Evaluation Report to IVDR Annex XIII.
Scientific validity reportsBased on structured literature appraisal linking analyte to condition.
Analytical performance reportsTied to defined acceptance criteria across the Annex I characteristics.
Clinical performance reportsIncluding integration of clinical performance study data.
PMPF plans and reportsPost-Market Performance Follow-up that keeps the evidence current.
Annex XIII gap analysisExisting evidence assessed against IVDR Annex XIII requirements.
How EvySaif helps
We prepare the full performance evaluation, from the plan that scopes the evidence to the report that concludes on your intended purpose. We document all three pillars, keep the PEP and PER aligned so a Notified Body finds no divergence, and connect the file forward to PMPF.
Why EvySaif
As one of the best research and medical writing consultancies in India, EvySaif brings genuine IVD delivery experience to performance evaluation, an area where specialist writers are hard to find. Our work is clinician-led, so the clinical performance section reflects how the result is actually used, and every claim is traceable to its evidence, which is exactly what survives Notified Body review.
Frequently asked questions
The Performance Evaluation Plan (PEP) is the roadmap of what evidence you will collect and how. The Performance Evaluation Report (PER) presents that evidence and the conclusions drawn from it. They must stay aligned.
Yes: scientific validity, analytical performance, and clinical performance, each documented to IVDR Annex XIII and EN ISO 20916:2024.
Not always. If existing literature and data sufficiently demonstrate clinical performance, a new study may not be needed. Where they do not, IVDR Annex XIII may require one.
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