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 lists what the PEP shall include as a general rule. If an element is not appropriate because of specific device characteristics, the plan must give a justification.
| Element | What the plan specifies |
|---|---|
| Intended purpose and intended use | A specification of the intended purpose and the intended use of the device. |
| Device characteristics | A specification of the device characteristics set out in Annex I, Chapter II, Section 9 and Chapter III, Section 20.4.1, point (c). |
| Analyte or marker | The analyte or marker to be determined by the device. |
| Metrological traceability | Certified reference materials or reference measurement procedures that allow for metrological traceability. |
| Target patient groups | Specified target patient groups, with clear indications, limitations and contra-indications. |
| Applicable requirements | The general safety and performance requirements in Annex I, Sections 1 to 9, that need support from scientific validity, analytical and clinical performance data. |
| Methods | Methods, including appropriate statistical tools, for examining analytical and clinical performance and the limitations of the device and the information it provides. |
| State of the art | A description of the state of the art, including relevant standards, common specifications, guidance and best practice documents. |
| Benefit-risk parameters | Parameters to determine, based on the state of the art in medicine, whether the benefit-risk ratio is acceptable for the intended purpose and for the analytical and clinical performance. |
| Software | For software qualified as a device, the reference databases and other data sources used as the basis for its decision making. |
| Development phases | An outline of the development phases, including the sequence and means of determining scientific validity, analytical and clinical performance, with milestones and potential acceptance criteria. |
| Post-market follow-up | PMPF planning as referred to in Annex XIII, Part B. |
Tip: scroll the table sideways on mobile to see all columns.
Consultant Support for Your Performance Evaluation Plan
For Class C and D devices, the PEP is a key part of the technical documentation, because it sets out the clinical evidence the manufacturer plans to generate or collect. I3CGLOBAL provides a simple data-collection methodology prepared for Notified Body review and ready for the final study strategy.
Our experts help outline the development phases in your PEP, including the sequence of studies, milestones and potential acceptance criteria.
Gap analysis
We assess legacy IVDD data against the stricter IVDR Annex XIII requirements.
Study design
Clinical performance studies are required unless due justification is provided for relying on other sources of clinical performance data. Where studies are needed, we work with CROs to design the protocols.
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 (consistent with the clinical evidence principles in 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. See anonymised examples in our IVDR CE marking case studies.
- PEP written to Annex XIII, Part A, including development phases and milestones
- 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.
Does the IVDR require a Clinical Development Plan in the PEP?
The IVDR does not use the term Clinical Development Plan. Annex XIII, Part A requires the PEP to outline the development phases, including the sequence and means of determining scientific validity, analytical and clinical performance, with milestones and potential acceptance criteria.
What must a Performance Evaluation Plan include?
It specifies the intended purpose, analyte, target groups, traceability, methods, state of the art, benefit-risk parameters, development phases with acceptance criteria, and PMPF planning, as set out in IVDR Annex XIII, Part A.
Does every IVD need a clinical performance study?
Not always. Clinical performance studies are the general expectation, but a manufacturer may rely on other sources of clinical performance data where this is justified. The PEP should document that justification.
How does the PEP relate to the PMPF plan?
The PEP includes PMPF planning, and the PMPF plan then sets out how performance data will be collected after market launch. Those findings feed back into the performance evaluation.