How do you create a Performance Evaluation Plan and Report that passes the notified body's IVDR review without deficiencies?
We prepare the Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER) for in vitro diagnostics under the In Vitro Diagnostic Regulation (EU) 2017/746, structured along the three pillars of scientific validity, analytical performance and clinical performance per Art. 56 and Annex XIII. The real decisive hurdle is not writing the report, but the sequence: the plan must come before data collection, otherwise the report ends up demonstrating evidence that was never planned for the specific intended purpose.
- IVD
- MedTech
Overview
What does the IVDR require of the Performance Evaluation Plan and Report?
PEP/PER across all three evidence pillars · IVDR (EU 2017/746), Art. 56, Annex XIII, EN ISO 14971
Last updated: 2026-06-13
The In Vitro Diagnostic Regulation (EU) 2017/746 replaced the IVD Directive 98/79/EC and has applied since 26 May 2022. Under Art. 56, performance evaluation is a continuous process that is steered through a documented plan and consolidated in a report. Four points where the notified body's review most often gets stuck:
- Three-pillar evidence per Art. 56: scientific validity (the link between the analyte and the clinical condition), analytical performance (the measurement accuracy of the device) and clinical performance. If a pillar is missing or not tied to the intended purpose, the performance evaluation is incomplete.
- The Performance Evaluation Plan must come before data collection. Annex XIII Part A requires a documented plan that defines the criteria, methods and evidence needs before data are collected and assessed in the report.
- Linkage to the General Safety and Performance Requirements in Annex I: the report must show that the demonstrated performance covers the GSPR for the specific intended purpose.
- Connection to post-market performance follow-up per Annex XIII Part B and post-market surveillance per Art. 75: the performance evaluation is not a final deliverable, but is updated across the entire lifecycle.
Services
How we support you
Performance Evaluation Plan (PEP)
Preparation of the plan per Annex XIII Part A: definition of the intended purpose, the three evidence pillars, the acceptance criteria and the methods for each pillar, as an audit-ready document before data collection begins.
Literature and validity analysis
Systematic literature review and appraisal to demonstrate scientific validity per Art. 56 and Annex XIII, documented with a search strategy, inclusion/exclusion criteria and a traceable assessment.
Performance Evaluation Report (PER)
Consolidation of scientific validity, analytical and clinical performance into the report per Annex XIII Part A, with complete linkage to the GSPR in Annex I and to the technical documentation.
PMPF plan & integration
Preparation of the post-market performance follow-up plan per Annex XIII Part B and linkage of PER, PMPF and post-market surveillance per Art. 75 into a continuous system.
Learn more →Evidence gap analysis
Gap analysis of the available data against the evidence needs per Art. 56; assessment of whether a performance study per Annex XIV is required, with a prioritized action list.
Update & maintenance
Establishment of the periodic update of PEP and PER from PMPF data, embedded in risk management per EN ISO 14971 and the technical documentation.
How we work together
What it comes down to
The In Vitro Diagnostic Regulation (EU) 2017/746 treats performance evaluation not as a single document, but as a process with a fixed sequence. Three pillars under Art. 56 must align: scientific validity demonstrates that the measured analyte is associated with the clinical condition. Analytical performance shows how accurately the device measures that analyte. Clinical performance demonstrates that the result is meaningful for the intended purpose. These pillars are first planned in the Performance Evaluation Plan per Annex XIII Part A and only then consolidated in the Performance Evaluation Report. Anyone who writes the report without a preceding plan ends up demonstrating evidence that was never defined for the specific intended purpose. That is the most common reason for deficiencies raised by the notified body.
This is exactly where we come in: the evidence gap analysis makes clear early on which pillar is critical, before data are collected and the report is written. If the available evidence is not sufficient for the acceptance criteria defined in the plan, a decision is made on a performance study per Annex XIV while there is still time for it. And because performance evaluation under Art. 56 is a continuous process, we connect the PER from the outset to the post-market performance follow-up per Annex XIII Part B and the post-market surveillance per Art. 75, so that new market data feed back into the report instead of letting it age in the surveillance audit.
Our approach
Our approach
Step
Result
Scope & intended purpose
Precise intended purpose of the IVD and the derived evidence needs for each pillar per Art. 56.
Performance Evaluation Plan
PEP per Annex XIII Part A: methods and acceptance criteria for scientific validity, analytical and clinical performance, defined before data collection.
Evidence collection & gap analysis
Literature analysis, evaluation of available data and a decision on whether a performance study per Annex XIV is needed.
Performance Evaluation Report
PER that consolidates the three pillars and demonstrates compliance against the GSPR in Annex I.
PMPF integration
PMPF plan per Annex XIII Part B, linked to post-market surveillance per Art. 75.
Lifecycle maintenance
An established update logic that keeps the PER current from PMPF data and connects it to risk management.
Common pitfalls
Where projects commonly fail
The report is written without a preceding plan.
Annex XIII Part A requires a documented plan before data collection; a PEP drafted after the fact demonstrates evidence that was never planned, and a notified body spots it immediately.
One of the three pillars per Art.
56 is missing or not tied to the intended purpose. Scientific validity in particular is underestimated, because the link between the analyte and the clinical condition is not demonstrated on its own but blended with analytical performance.
PEP/PER are confused with the clinical counterparts under the MDR (CEP/CER).
Under the IVDR (EU) 2017/746, its own terminology and structure per Annex XIII apply; templates carried over from the MDR lead to the wrong pillars and to deficiencies.
The PMPF per Annex XIII Part B is not connected to the PER.
Without a documented update logic, the performance evaluation ages, and the gap surfaces in the surveillance audit because new market data do not feed back into the report.
The linkage between the PER and the GSPR in Annex I stays generic.
For the relevant performance requirements, the notified body expects a specific link to the demonstrated performance; broad references generate findings instead of a clean path through the review.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/746 (IVDR), primary text: Art. 56, 75, 76, Annex I, XIII (Parts A and B), XIV
- EN ISO 14971, Application of risk management to medical devices
- https://theentourage.de/clinical-medical-affairs/performance-evaluation-plan-report/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- Regulation (EU) 2017/746 (IVDR)
- IVDR Art. 56 (performance evaluation and clinical evidence)
- IVDR Annex XIII Part A (performance evaluation and performance studies)
- IVDR Annex XIII Part B (post-market performance follow-up, PMPF)
- IVDR Annex XIV (performance studies)
- IVDR Annex I (General Safety and Performance Requirements, GSPR)
- IVDR Art. 75 (post-market surveillance)
- IVDR Art. 76 (vigilance)
- EN ISO 14971 (risk management)
Related topics
IVDR Readiness →
The full path to IVDR conformity under EU 2017/746
IVD Performance Studies →
Performance studies per Annex XIV when the evidence is not sufficient
Post-Market Surveillance →
PMPF per Annex XIII Part B and PMS per Art. 75 in detail
Clinical Evaluation MDR →
The counterpart CEP/CER for medical devices under EU 2017/745
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