Performance Evaluation Report Writing for IVD Manufacturers
Pubrica writes IVDR performance evaluation reports for in vitro diagnostic manufacturers. Our IVD performance evaluation writers prepare performance evaluation plans and reports under IVDR Annex XIII, with scientific validity, analytical performance and clinical performance each built on its own evidence. Keeping the three separate gives the Notified Body a clear basis for assessment.
- Three legs, argued separately — scientific validity, analytical performance and clinical performance, each with its own evidence and its own conclusion
- A scientific validity report that stands alone, because for many assays this leg rests on literature rather than on your own data
- Plan before report — the performance evaluation plan sets the intended purpose, the analyte-condition link and the acceptance criteria
- A documented literature route where scientific validity is established from published evidence, with a reproducible protocol, search and appraisal
- PMPF linked from the start, so the gaps the report leaves are the gaps the follow-up plan closes
Performance evaluation plan and reportIncluded
Scientific validity reportIncluded
Analytical and clinical performance sectionsIncluded
PMPF plan linkageIncluded
Notified Body assessmentTheir role
Intended purpose → plan → evidence → argued → report
- Three legs argued separately
- Scientific validity documented
- Acceptance criteria set in the plan
- Literature route reproducible
- PMPF gaps identified
Deliverables
Performance Evaluation Report Deliverables
Each evaluation covers one device and one intended purpose, and the link between analyte and condition defines what the evaluation must establish.
Example from a scientific validity reportFor many assays this leg rests entirely on published evidence, and it is the leg most often left implicit. A Notified Body cannot assess an unstated assumption.
Example from an analytical performance sectionThe assay demonstrated acceptable analytical performance.LoD 0.8 ng/mL against a criterion of ≤1.0; within-run CV 3.2% against ≤5%; no interference at the tested concentrations for eleven substances. Acceptable against what, stated.
Example from a clinical performance sectionWhere the comparator is an imperfect reference standard, saying so and quantifying the effect is stronger than presenting the numbers as though it were perfect.
Example from a performance evaluation planWithout a plan, acceptance criteria may be chosen after the results are known. Reviewers therefore ask to see the plan.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Performance Evaluation Report Regulatory and Quality Standards
Where your Notified Body has a stated position, that position takes precedence.
In Vitro Diagnostic Regulation (Annex XIII)
The legal requirement for performance evaluation: the plan, the three legs, the report and the post-market performance follow-up.
MDCG guidance for IVDs (performance evaluation series)
The working interpretation Notified Bodies apply, including on scientific validity and on what counts as sufficient evidence for each leg.
Clinical performance studies for IVDs (good study practice)
Where clinical performance rests on your own study using specimens from human subjects, this is the good study practice standard it is held to.
Quality management (cert. H3CR9TCU20251212INDQM10N)
How the document is drafted, reviewed, version-controlled and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to its evidence and to a responsible individual. For this reason, we treat source traceability as more important than drafting speed, and every statement in a regulatory document must be traceable to its source.
Why We Do Not Publish an AI Accuracy Figure
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How We Write Your Performance Evaluation Report
The intended purpose statement governs the whole evaluation. If it is written loosely, the evidence burden increases in every direction.
Intended purpose and plan
We define the analyte, the condition, the population, the setting and the clinical decision the result informs, then set the evidence sources and acceptance criteria for each of the three legs.
Scientific validity
We establish the association between analyte and condition from literature, guidance or your own data, and document the search where the route is literature.
Analytical and clinical performance
We assemble the study data and assess it against the criteria in the plan, identifying gaps rather than absorbing them.
Report and PMPF linkage
We write the report for Notified Body assessment and route any residual gaps into the post-market performance follow-up plan.
Our Experts
Our Performance Evaluation Report Writing Team
A named team of regulatory specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
Performance Evaluation Report Writing Packages
Pricing depends on device class, the analyte, how much of the evidence is based on literature and whether a plan already exists.
Performance evaluation plan and report
For IVD manufacturers preparing or rebuilding a technical file
Quoted per projectOn class, analyte and evidence volume
Delivery By scope
- ✓Performance evaluation plan with acceptance criteria
- ✓Scientific validity report
- ✓Analytical performance section
- ✓Clinical performance section
- ✓Documented literature search where the route is literature
- ✓PMPF gaps identified and routed
Plan and report are quoted together because the plan is what makes the report assessable.
Deliverables Request a quotePER update and PMPF report
For devices on the market with an existing evaluation
Quoted per projectOn new evidence volume
Delivery By scope
- ✓New literature and PMPF data incorporated
- ✓Scientific validity reassessed where the field has moved
- ✓Performance claims re-checked against current evidence
- ✓Standards citations brought current
- ✓Next update cadence documented
IVDR requires updates on a regular cycle, so we document the update cadence in the report.
Deliverables Request a quoteSend us your current performance evaluation, and we will tell you free of charge which of the three legs is least supported. In our experience, it is usually scientific validity, which reviewers often ask about first.
FAQs
Performance Evaluation Report FAQs
If your question is not answered here, ask an expert — no quote is required.
Scientific validity is the association between the analyte and the clinical condition. Analytical performance is whether the assay measures the analyte accurately. Clinical performance is whether the result is clinically useful in the intended population.
They are separated because they rest on different evidence and can fail independently. An assay can be analytically excellent and clinically useless, and a report that blends the legs hides which is which.
Yes, and for many established analytes it does. What IVDR requires is that the route is documented — a search protocol, appraisal criteria and a reproducible result rather than a reading list.
This is the leg most often left implicit because the association is considered well known. A well-known association still requires a citation.
Different regulation, different structure. A clinical evaluation report is a medical device document under MDR Annex XIV; a performance evaluation report is an IVD document under IVDR Annex XIII.
The approach is the same, with a documented search, stated criteria and evidence argued rather than asserted, but the structures are not interchangeable, and a CER template used for an IVD is readily identified.
Yes, and they belong together. The performance evaluation identifies what is not yet established; the post-market performance follow-up plan says how it will be.
When the two are written separately, the gaps identified in one are rarely the gaps addressed in the other, which is itself a finding.
Related Services
Related IVD and Clinical Evaluation Services
The PER is the IVD counterpart of the clinical evaluation report and draws on the same evidence methods.
1MEDICAL DEVICE EVALUATIONsame discipline, different regulation
Clinical evaluation reportEU MDR Annex XIV. Regulatory writingTechnical documentation and submissions.2SUPPORTING EVIDENCEsources of evidence for each leg
Systematic reviewDocumented search, screening and appraisal. Literature review and gap analysisWhat is established and where it stops.3STATISTICAL ANALYSISanalysis and reporting
BiostatisticsSensitivity, specificity and agreement analysis. Meta-analysisPooled diagnostic accuracy across studies.Request a Free Review of Your Performance Evaluation Report
We will tell you free of charge which of the three legs is least supported. It is usually scientific validity, which reviewers often ask about first.