IVDR Performance Evaluation Report
An IVDR performance evaluation report (PER) is the cornerstone of your technical documentation. It is the primary evidence that your in vitro diagnostic device achieves its intended purpose safely, built on scientific validity, analytical performance and clinical performance data under Annex XIII of Regulation (EU) 2017/746. This guide explains what a notified-body-ready PER contains and how I3CGlobal builds one.
What is an IVDR Performance Evaluation?
IVDR performance evaluation is a continuous process of collecting, appraising and analysing data on a specific IVD device to verify its scientific validity, analytical performance and clinical performance. Compared with the old IVD Directive (98/79/EC), the IVDR demands a far more structured, data-driven and documented approach.
The results are documented in the IVD performance evaluation report, which must be kept up to date throughout the product lifecycle using data from your Post-Market Performance Follow-up (PMPF).
Our regulatory experts bridge the gap between Annex XIII requirements and the latest MDCG guidance, from clinical evidence principles in MDCG 2022-2 to legacy device transitions, so your PER is written for full notified body alignment.
Key Components of a Compliant IVDR Performance Evaluation Report
To ensure a smooth certification process, the IVDR performance evaluation report must follow Annex XIII and Article 56 of the IVDR. A PER that convinces a notified body is built on three strong pillars of evidence:
Scientific validity
Evidence that the analyte or marker is associated with the intended clinical condition or physiological state.
Analytical performance
Sensitivity, specificity, accuracy, precision and limits of detection that prove the device correctly detects or measures the analyte and justify every IFU claim.
Clinical performance
Clinically relevant correlation between the device results and the target condition in the intended user and patient population.
Presentation: IVDR performance evaluation report. Use the full-screen button to view the slides.
Don’t let CE marking delay your EU market entry. Get expert guidance on your IVDR PER and technical documentation.
Why Your Technical File Needs a Professional IVDR PER
Whether you manufacture Class A, B, C or D devices, a performance evaluation report is mandatory. The depth of evidence, however, rises with the IVDR classification of the device. For high-risk Class C and Class D devices the PER needs extensive clinical evidence and often a clinical research organisation (CRO) to run performance studies.
| Class | Notified body review of the PER | Post-market output | SSP |
|---|---|---|---|
| Class A | No, self-declared (sterile aspects only for Class A sterile) | PMS report, PER updated as PMS data requires | Not required |
| Class B | Yes, sampled technical documentation per device category | PMS report, PER updated as PMS data requires | Not required |
| Class C | Yes, technical documentation per generic device group | PSUR, PER and PMPF evaluation updated at least annually | Required |
| Class D | Yes, every device, plus EU reference laboratory verification | PSUR, PER and PMPF evaluation updated at least annually | Required |
- We develop a detailed Performance Evaluation Plan (PEP) before any data collection begins.
- We map every claim in the report to the General Safety and Performance Requirements (GSPR) and to the right records in the technical documentation.
- Our in-house methodology reduces notified body review comments and certification delays.
How We Build Your IVDR Performance Evaluation Report
Every PER we write follows the same documented route, so the evidence is complete, traceable and ready for notified body review.
- Performance Evaluation PlanDefine the intended purpose, analytes, claims, state of the art and evidence strategy in a PEP agreed with your team.
- Scientific validitySystematic literature search and appraisal to build the scientific validity report.
- Analytical performanceReview or plan verification studies and compile the analytical performance report.
- Clinical performanceGather clinical performance data from literature, routine testing or studies, coordinating with a CRO where needed.
- Compile the PERIntegrate all evidence, benefit-risk and GSPR mapping into one PER and, for Class C and D, the SSP.
- Keep it currentFeed PMPF and PMS data back into the PER throughout the device lifecycle.
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Expert IVDR Performance Evaluation Services
Moving from the IVDD to the IVDR is challenging. Our consultants give end-to-end support for your IVDR performance evaluation, from literature searches and state-of-the-art analysis to the final compilation of the PER, so your products reach the market faster.
- IVDR Performance Evaluation Plan (PEP) developed with the manufacturer
- Scientific validity, analytical performance and clinical performance reports
- Coordination with a third-party clinical research organisation if required
- Integration of the PER into your quality management system (QMS)
- Gap analysis of existing IVDD data against IVDR requirements
Get a Notified-Body-Ready IVDR Performance Evaluation Report
Our IVDR consultants plan, write and maintain your performance evaluation for Class A through Class D devices.
- Performance evaluation plan and strategy
- Scientific validity and analytical performance
- Clinical performance and CRO coordination
- Notified body query support
IVDR Performance Evaluation Report: Frequently Asked Questions
Is performance evaluation a continuous process?
Yes. Performance evaluation under the IVDR is continuous. Evidence is gathered throughout the lifespan of the device, mainly through the post-market performance follow-up (PMPF) process, and the PER is updated with the results.
What is the difference between a performance evaluation plan and a performance evaluation report?
The performance evaluation plan (PEP) defines in advance what evidence is needed and how it will be gathered. The performance evaluation report (PER) documents the results, the analysis and the conclusion that the device meets the relevant general safety and performance requirements.
What are the three pillars of IVDR performance evaluation?
Scientific validity, analytical performance and clinical performance. Together they show that the analyte is linked to the clinical condition, that the device measures it correctly, and that the results are clinically meaningful for the intended population.
Do Class A devices need a performance evaluation report?
Yes. A PER is required for every IVD class. For non-sterile Class A devices the notified body does not review it before CE marking, but competent authorities can request it at any time.
How often must the PER be updated?
The PER is updated throughout the lifecycle with PMS and PMPF data. For Class C and Class D devices the PER, together with the PMPF evaluation, must be updated at least annually.
Can we reuse data from our IVDD technical file?
Often, yes. Existing data can support the PER if it meets IVDR requirements and reflects the current state of the art. A gap analysis shows what can be reused and what new evidence is needed; MDCG 2022-2 sets out the general principles of clinical evidence.
Do we always need a new clinical performance study?
Not always. Clinical performance can be demonstrated using published literature, routine diagnostic testing data or performance studies. Higher-risk and novel devices more often need studies, and some study types require authorisation under the IVDR.
What is the Summary of Safety and Performance (SSP)?
Class C and Class D devices need an SSP, a public summary of the performance evaluation written for users and, where relevant, patients. It must be consistent with the PER and is validated by the notified body.
