IVDR Performance Evaluation Plan (PEP)
We help IVD manufacturers build a Performance Evaluation Plan that meets IVDR Annex XIII, Part A, covering scientific validity, analytical performance and clinical performance, with acceptance criteria a Notified Body can follow.
What Is a Performance Evaluation Plan under IVDR?
Under EU IVDR 2017/746, the Performance Evaluation Plan (PEP) is a mandatory document. It sets out what will be done, how, when and with which methods to show that an IVD device performs as intended, safely and effectively, throughout its lifecycle.
The PEP is described in IVDR Annex XIII, Part A. It is not a one-time document: it must be reviewed and updated as new performance and post-market data become available.
Scientific validity
Is the analyte or marker associated with the clinical condition or physiological state? See our scientific validity report guide.
Analytical performance
Does the device measure the analyte correctly, in terms of precision, trueness, sensitivity and specificity? Learn more about IVD analytical performance.
Clinical performance
Does the device give results that lead to the correct clinical decision for the intended patient population?
Why a Performance Evaluation Plan Matters
A well-developed PEP keeps the performance evaluation aligned with IVDR and MDCG guidance. It documents the scientific rationale for each method the manufacturer selects and follows.
The plan must state acceptance criteria for every method used, and explain how the acceptability of the benefit-risk ratio will be assessed. A clear plan also makes the later Performance Evaluation Report (PER) easier to write and defend.
Practical steps for drafting a strong PEP
Link claims to intended use
Every performance claim must trace back to the intended purpose. If you claim "early detection", plan studies that prove performance in early-stage patients.
Gap-check legacy devices
For devices already on the market, use the PEP to identify where existing IVDD data falls short of IVDR requirements.
Plan metrological traceability
Identify certified reference materials or reference procedures so your results are traceable.
Cover software-based IVDs
For software IVDs (SaMD), add supporting evidence and describe the reference databases and data sources used for decision-making.
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Core Sections of a Performance Evaluation Plan
IVDR Annex XIII, Part A sets out what the PEP must contain. The table below summarises each section and its mandatory content.
| Section | Mandatory content |
|---|---|
| General performance evaluation requirements | Planning, conduct and documentation of the performance evaluation to show compliance with the Annex I GSPRs. |
| Device identification | Device name, trade name, model(s), version, UDI (if applicable) and device classification. |
| Intended purpose | Medical purpose, analyte(s), specimen type, testing principle, intended user and use environment. |
| Target population | Intended patient population, disease condition, demographics and clinical setting. |
| Performance claims | Clearly defined, measurable claims from the IFU, labelling and promotional materials. |
| Scientific validity claims | Claims showing the association between the analyte and the clinical condition. |
| Analytical performance claims | Accuracy, precision, sensitivity, specificity, LoD, LoQ, linearity and related parameters. |
| Clinical performance claims | Diagnostic sensitivity, diagnostic specificity and predictive values. |
| Performance evaluation strategy | Strategy to demonstrate scientific validity, analytical performance and clinical performance. |
| Performance evaluation data planning | Identification, generation and appraisal of performance evaluation data. |
| Acceptance criteria | Pre-defined acceptance criteria justified against the state of the art. |
| Data sources and methodology | Literature search, study protocols and data appraisal methods. |
| Lifecycle performance evaluation | PMS and PMPF integration, periodic review and defined update triggers. |
Tip: scroll the table sideways on mobile to see all columns.
Consultant Support for Your Performance Evaluation Plan
For high-risk Class C and D devices, the PEP is the most critical document in the technical documentation, because it dictates what clinical evidence the manufacturer must collect. I3CGLOBAL provides a simple data-collection methodology accepted by Notified Bodies and ready for the final study strategy.
Our experts help define the Clinical Development Plan (CDP), a mandatory part of the PEP for Class C and D devices.
Gap analysis
We assess legacy IVDD data against the stricter IVDR Annex XIII requirements.
Study design
Literature alone is not enough for Class C and D. We work with CROs to design prospective clinical performance study protocols that satisfy a Notified Body.
Expert panel preparation
For Class D devices, we support the documentation needed for EU Expert Panel and EURL reviews.
GSPR and risk alignment
Weak evidence traceability is a common reason for NB rejection. We integrate your PEP with the Annex I GSPRs and benefit-risk analysis.
PMPF and lifecycle
We draft the Post-Market Performance Follow-up (PMPF) plan so data collection continues after market launch.
Coordination and NB audit
We coordinate with clinical research organisations and answer NB queries on statistical methods and data choices.
We draft the three fundamental sub-plans
Scientific validity plan
A systematic literature search protocol (per MDCG 2022-2) to prove the association between your analyte and the clinical condition.
Analytical performance plan
Sensitivity, specificity, LoD and LoQ parameters with acceptance criteria based on state-of-the-art standards.
Clinical performance plan
How diagnostic accuracy (PPV, NPV, likelihood ratios) will be validated in the target population.
Performance Evaluation Plan Support from I3CGLOBAL
Our IVDR consultants support IVD manufacturers worldwide across all risk classes, from Class A to Class D.
- PEP and Clinical Development Plan written to Annex XIII, Part A
- State-of-the-art acceptance criteria for every performance claim
- Gap assessment of legacy IVDD performance data
- PEP aligned with your Performance Evaluation Report and PMPF plan
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IVDR Quote Request Contact UsFrequently Asked Questions
Is a Performance Evaluation Plan (PEP) mandatory for all IVD devices?
Yes. A PEP is mandatory for all IVD devices, whatever their risk class. It defines the strategy, data sources, acceptance criteria and methods used to generate and evaluate performance evidence. It must be in place before the device is placed on the market and maintained throughout its lifecycle, including post-market performance follow-up (PMPF).
What happens if gaps are identified during IVDR performance evaluation?
The manufacturer must perform a gap analysis and generate the additional performance data needed. This may include analytical studies, clinical performance studies or literature-based evidence. Unaddressed gaps are a common reason for Notified Body non-conformities and certification delays.
What is the difference between the PEP and the PER?
The PEP is the plan: it defines what evidence is needed and how it will be generated and assessed. The Performance Evaluation Report (PER) documents the results of that evaluation and concludes whether the device meets the GSPRs.
How often should the PEP be updated?
The PEP should be updated whenever new information affects the performance evaluation, such as PMS or PMPF findings, design changes, new claims or changes to the state of the art. Class C and D devices are also subject to more frequent review cycles linked to their PSUR.
Is a Clinical Development Plan required in the PEP?
For Class C and D devices, the PEP must include a Clinical Development Plan that describes the progression from exploratory studies to confirmatory clinical performance studies and PMPF.