Published: 20th July 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
Why Notified Bodies Reject IVDR Performance Evaluation Reports: The Top 3 Mistakes Manufacturers Make
The Performance Evaluation Report (PER) is one of the most heavily scrutinised documents within an IVDR technical file. Under Regulation (EU) 2017/746, manufacturers must demonstrate that sufficient scientific validity, analytical performance and clinical performance evidence supports the intended purpose of their in vitro diagnostic (IVD) device.
While many manufacturers focus on generating evidence, Notified Bodies frequently identify deficiencies in how that evidence is justified, organised and linked throughout the technical documentation. A technically sound device can still experience lengthy review cycles if the Performance Evaluation Report lacks traceability or does not clearly demonstrate compliance with Annex XIII.
This article examines three of the most common Performance Evaluation deficiencies identified during IVDR conformity assessments and explains how manufacturers can reduce the risk of delays during Notified Body review.
New to the EU IVDR?
If you're looking for a complete introduction to Regulation (EU) 2017/746, including IVD classification, Performance Evaluation, Technical Documentation, Notified Bodies, UDI, EUDAMED and post-market requirements, explore our Complete Guide to the EU IVDR.
Could an Incorrect IVDR Classification Delay Your Submission?
A strong Performance Evaluation Report starts with correctly classifying your IVD. If you're unsure how the seven IVDR classification rules are applied, how to determine whether your device is Class A, B, C or D, or what your classification means for Performance Evaluation and Notified Body assessment, explore our Complete Guide to IVDR Classification.
1. Weak Scientific Validity and Poor State of the Art Justification
One of the first areas reviewed by a Notified Body is whether the manufacturer’s scientific rationale genuinely supports the intended purpose of the device.
A common mistake is presenting the State of the Art (SoTA) as a general overview of the disease or biomarker rather than demonstrating what current clinical practice expects from equivalent diagnostic technologies.
Typical deficiencies include:
- acceptance criteria that appear arbitrary
- limited discussion of existing diagnostic methods
- no justification for claimed performance targets
- outdated or poorly referenced clinical guidance
- conclusions that are unsupported by the cited evidence
When reviewers cannot understand how performance expectations were established, confidence in the remainder of the Performance Evaluation quickly diminishes.
Rather than asking whether your device performs well, Notified Bodies are asking whether you have objectively demonstrated what “good performance” should look like before evaluating your own data.
Further reading: Learn how to prepare a compliant Scientific Validity Report and establish an appropriate State of the Art in our complete guide to Scientific Validity under the IVDR.
2. Literature Reviews That Cannot Be Reproduced
IVDR requires literature reviews to be systematic, transparent and reproducible.
One of the most common reasons for review comments is that manufacturers provide a summary of published evidence without demonstrating how that evidence was identified or selected.
Examples of common deficiencies include:
- undocumented search strategies
- missing database information
- unclear inclusion and exclusion criteria
- failure to discuss conflicting evidence
- limited critical appraisal of study quality
If another reviewer cannot repeat your search and obtain substantially the same evidence base, the robustness of the Performance Evaluation becomes difficult to verify.
Notified Bodies are not simply assessing the conclusions reached within the report—they are also assessing the methodology used to reach those conclusions.
Further reading: Our guide to IVDR Scientific Literature Reviews explains how to develop a systematic, reproducible literature review that supports Performance Evaluation.
3. Poor Traceability Between the Three Performance Evaluation Pillars
Perhaps the most significant issue identified during IVDR reviews is the lack of alignment between Scientific Validity, Analytical Performance and Clinical Performance.
Although these are often produced as separate documents, Notified Bodies expect them to function as one coherent evidence package.
Common examples include:
- intended purpose statements that differ between reports
- analytical studies performed using different specimen types from those described elsewhere
- clinical performance studies that do not support the intended patient population
- Instructions for Use containing claims that are not supported by the available evidence
- Risk Management documentation that does not reference identified performance limitations
Even where each individual report appears technically acceptable, inconsistencies between documents often result in requests for clarification and additional evidence.
A strong Performance Evaluation tells one consistent evidence story from intended purpose through to post-market activities.
What Reviewers Expect to See
Before submitting an IVDR technical file, manufacturers should ensure there is clear alignment between the following documents.
| Document | Should align with |
|---|---|
| Intended Purpose | Instructions for Use |
| Scientific Validity Report | Intended Purpose |
| Analytical Performance Report | Scientific Validity |
| Clinical Performance Report | Analytical Performance |
| Performance Evaluation Report | All three evidence pillars |
| Risk Management File | Performance evidence |
| Labelling and IFU | Supported clinical claims |
| PMPF Plan | Remaining evidence gaps |
The clearer these relationships are, the easier it is for reviewers to follow the evidence supporting the safety and performance of the device.
Avoiding Unnecessary Review Cycles
Many IVDR review comments arise not because evidence is missing, but because the evidence is difficult to follow.
Manufacturers can significantly reduce the likelihood of additional questions by ensuring:
- performance objectives are clearly justified
- literature reviews follow a documented methodology
- all three evidence pillars remain consistent
- intended purpose is identical throughout the technical documentation
- clinical claims are fully supported by the available evidence
- traceability between documents is maintained
A well-structured Performance Evaluation Report enables reviewers to understand the evidence efficiently and demonstrates that the manufacturer’s conclusions are objective, transparent and scientifically justified.
Final Thoughts
Preparing an IVDR Performance Evaluation Report is no longer simply an exercise in compiling data. Manufacturers must demonstrate a clear, logical and traceable evidence pathway that links scientific validity, analytical performance and clinical performance to every clinical claim made for the device.
Many Notified Body review findings are entirely avoidable with careful planning and consistent documentation. By addressing common deficiencies before submission, manufacturers can reduce review cycles, minimise requests for additional information and improve the efficiency of the conformity assessment process.
If you are preparing an IVDR submission and would like an independent review of your Performance Evaluation documentation before Notified Body assessment, our regulatory specialists can help identify potential deficiencies and strengthen your technical documentation before submission.
Frequently Asked Questions
Notified Bodies typically raise deficiencies when the Performance Evaluation Report does not provide sufficient evidence to support the intended purpose of the IVD. Common issues include weak scientific justification, incomplete literature reviews, poor traceability between Scientific Validity, Analytical Performance and Clinical Performance, and inconsistencies across the technical documentation.
One of the most common deficiencies is a lack of traceability between the three pillars of Performance Evaluation. Reviewers expect Scientific Validity, Analytical Performance and Clinical Performance evidence to support the same intended purpose, patient population, specimen type and clinical claims throughout the technical documentation.
Yes. Completing the necessary studies does not automatically result in an acceptable Performance Evaluation Report. Notified Bodies also assess how the evidence is presented, justified and linked together. Poor organisation, inconsistent documentation or unsupported conclusions can all result in deficiencies.
The manufacturer will normally receive a list of questions or non-conformities that must be addressed before the conformity assessment can continue. Depending on the complexity of the issues, this may require additional evidence, revised documentation or further clarification, potentially delaying certification.
Yes. All in vitro diagnostic medical devices subject to Regulation (EU) 2017/746 require Performance Evaluation. The scope and complexity of the supporting evidence will depend on the device classification, intended purpose and associated risks.
The Performance Evaluation Report should align with the Intended Purpose, Instructions for Use, Risk Management File, labelling and other technical documentation. Inconsistencies between these documents are frequently identified during Notified Body reviews because they can undermine confidence in the manufacturer's evidence.
Published literature may contribute to the Performance Evaluation where appropriate, particularly when demonstrating Scientific Validity. However, manufacturers must ensure that the evidence is relevant to their specific device, critically appraised and sufficient to support the intended purpose and claimed performance.
Manufacturers can reduce the likelihood of deficiencies by ensuring their Performance Evaluation documentation is well structured, evidence-based and fully traceable. Performing an independent technical documentation review before submission can also help identify gaps and inconsistencies that may otherwise result in additional Notified Body questions.
References
This guide is based on the following legislation, international standards and official regulatory guidance relating to IVDR Performance Evaluation, scientific evidence and Notified Body conformity assessment.
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) | Provides the legal framework for Performance Evaluation, including the Annex XIII requirements for Scientific Validity, Analytical Performance and Clinical Performance that underpin every IVDR Performance Evaluation Report. |
| European Commission | MDCG Endorsed Documents and Other Guidance | Provides official Medical Device Coordination Group (MDCG) guidance supporting Performance Evaluation, technical documentation, scientific evidence and conformity assessment under the IVDR. |
| European Commission | Notified Bodies for Medical Devices | Provides official information on the role and responsibilities of Notified Bodies responsible for assessing Performance Evaluation documentation during IVDR conformity assessment. |
| International Organization for Standardization (ISO) | ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes | Defines the internationally recognised Quality Management System requirements supporting the preparation, review and maintenance of Performance Evaluation documentation. |
| International Organization for Standardization (ISO) | ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices | Provides the internationally recognised framework for integrating risk management with Performance Evaluation, technical documentation and post-market activities throughout the device lifecycle. |
| European Commission | EUDAMED – European Database on Medical Devices | Provides official information on EUDAMED, supporting lifecycle traceability, vigilance and regulatory transparency for IVDR-certified IVDs. |
Performance Evaluation requirements, conformity assessment expectations and regulatory guidance continue to evolve. Manufacturers should always consult the latest published legislation, recognised standards and official guidance when preparing Performance Evaluation Reports and supporting technical documentation for IVDR conformity assessment.
Patient Guards Recent Posts
IVDR Performance Evaluation Explained: A Complete Guide for Manufacturers
Performance Evaluation is one of the most important requirements under the EU In Vitro Diagnostic Regulation (IVDR). Every manufacturer must demonstrate that their in vitro diagnostic medical device achieves its intended purpose through robust scientific validity, analytical performance and clinical performance evidence. This guide explains every stage of IVDR Performance Evaluation, including Performance Evaluation Plans (PEPs), Performance Evaluation Reports (PERs), Post-Market Performance Follow-up (PMPF) and how Performance Evaluation supports successful CE marking under Regulation (EU) 2017/746.
IVDR Classification Explained: A Complete Guide to Class A, B, C and D IVDs
Understanding how your in vitro diagnostic device is classified under the EU IVDR is one of the first and most important steps towards regulatory compliance. This guide explains the IVDR classification rules, the differences between Class A, B, C and D IVDs, how Annex VIII is applied, and how classification affects conformity assessment, technical documentation and Notified Body involvement.
When Do You Need New Biocompatibility Testing for a Medical Device?
A material change, supplier switch, manufacturing transfer or design modification does not automatically require new ISO 10993 biocompatibility testing. Learn how manufacturers use Biological Evaluation Plans (BEPs), chemical characterisation, toxicological risk assessments and Biological Evaluation Reports (BERs) to determine whether existing biological evidence remains valid or whether additional testing is required under ISO 10993-1, the EU MDR and FDA expectations.
Need Training?
Do you need training on Quality Management Systems or EU MDR/ EU IVDR? then check out our training courses.
