IVDR Performance Evaluation: PEP, PER & PMPF for IVDs
We plan and write your IVDR performance evaluation, from the Performance Evaluation Plan through scientific validity, analytical and clinical performance to the Performance Evaluation Report, SSP and PMPF, so your clinical evidence stands up to Notified Body review.
What is IVDR performance evaluation?
Performance evaluation is the ongoing process of assessing data to show that your IVD achieves its intended purpose and delivers clinical evidence in line with Article 56 and Annex XIII of IVDR 2017/746.
It rests on three pillars: scientific validity, analytical performance and clinical performance. The evidence must match your device class and claims, and it is reviewed by your Notified Body for Class B, C and D devices. MDCG 2022-2 gives the general principles.
The three pillars of IVD clinical evidence
Each pillar answers a different question. Together they make up the clinical evidence for your IVD.
| Pillar | Question it answers | Typical evidence |
|---|---|---|
| Scientific validity | Is the analyte associated with the clinical condition? | Literature, textbooks, consensus guidelines, earlier studies |
| Analytical performance | Does the device correctly detect or measure the analyte? | Precision, trueness, limits of detection, interference, cross-reactivity and stability studies |
| Clinical performance | Do results correlate with the clinical condition in the target population? | Clinical performance studies, literature, routine diagnostic testing data, PMPF |
PEP, PER, SSP and PMPF: what each document does
Your performance evaluation file is a set of linked documents that must stay consistent with each other and with the technical file.
| Document | Purpose | When |
|---|---|---|
| Performance Evaluation Plan (PEP) | Defines intended purpose, evidence needed, methods and acceptance criteria | Before evidence is gathered |
| Performance Evaluation Report (PER) | Presents and evaluates all scientific validity, analytical and clinical performance data | Before certification, then throughout the lifecycle |
| Summary of Safety and Performance (SSP) | Public summary validated by the Notified Body and published in EUDAMED | Class C and D devices |
| PMPF plan & report | Collects post-market performance data to confirm or update the evidence | Ongoing; feeds the PER and PSUR |
How we carry out your performance evaluation
A structured route from evidence planning to a PER your Notified Body can accept.
- 1
Define intended purpose & claims
FoundationWe confirm the analyte, specimen, target population, intended user and every performance claim.
- 2
Performance Evaluation Plan
Annex XIII, Part AWe set out the evidence needed for each pillar, the methods and the acceptance criteria.
- 3
Scientific validity
LiteratureWe run a systematic literature review to show the analyte–condition link.
- 4
Analytical performance
StudiesWe plan analytical studies, review protocols and reports, and identify gaps.
- 5
Clinical performance
Studies · dataWe assess literature and existing data and, where needed, design clinical performance studies to ISO 20916.
- 6
Performance Evaluation Report
PER · SSPWe write the PER with a benefit-risk conclusion, and the SSP for Class C and D devices.
- 7
Post-market follow-up
PMPFWe set up the PMPF plan and update the PER and SSP with new data.
Analytical performance characteristics we cover
Common performance evaluation gaps
Our IVDR performance evaluation services
IVDR performance evaluation FAQs
Is performance evaluation mandatory under IVDR?
Yes. Article 56 requires a performance evaluation for every IVD, from Class A to Class D. It must be planned in a Performance Evaluation Plan, documented in a Performance Evaluation Report and kept up to date throughout the device lifecycle.
What are the three pillars of IVDR performance evaluation?
Scientific validity (the link between the analyte and the clinical condition), analytical performance (how well the device detects or measures the analyte) and clinical performance (how well results correlate with the clinical condition in the target population).
How often must the Performance Evaluation Report be updated?
Throughout the device lifecycle as new data comes in. For Class C and D devices, the PER must be updated with post-market performance follow-up (PMPF) data at least once a year.
Can literature replace performance studies?
Partly. Scientific validity is often shown through literature and established knowledge. Analytical performance normally needs your own studies. Clinical performance can draw on literature and routine diagnostic data, but gaps usually need a clinical performance study.
Do clinical performance studies need approval?
Some do. Studies with surgically invasive sample collection, interventional studies, studies with additional risks to subjects and certain companion diagnostic studies need authorisation or notification under IVDR Article 58, plus ethics committee review. ISO 20916 sets good study practice.
Can I reuse IVDD performance data?
Often yes, if it is still relevant to the current device and intended purpose and meets IVDR expectations. We assess legacy data against Annex XIII and fill gaps with targeted studies or PMPF.
Is your clinical evidence ready for IVDR?
Send us your IVD details using the form below and we'll identify your performance evidence gaps at no cost.
