Performance Evaluation Plan Writing for IVD Manufacturers
Pubrica writes IVDR performance evaluation plans for in vitro diagnostic manufacturers. Under IVDR Annex XIII Part A, the plan must specify how scientific validity, analytical performance and clinical performance will each be evidenced before any evidence is gathered. Our IVD performance evaluation writers prepare plans that address all three pillars separately, with an evidence route and acceptance criteria for each.
- All three pillars planned separately — scientific validity, analytical performance and clinical performance each have their own evidence route
- Required by IVDR Annex XIII Part A, and assessed on its own merits by the notified body
- Intended purpose written to the level of the assay claim: analyte, function, specimen type, population, user and testing environment
- Acceptance criteria per pillar, derived from the state of the art rather than from the results of your validation
- PMPF planned from the gaps, because post-market performance follow-up closes evidence gaps that cannot be addressed before market
Scientific validity route specifiedIncluded
Analytical performance planIncluded
Clinical performance planIncluded
Acceptance criteria per pillarIncluded
Combining the three pillarsThe most common PEP failure
Purpose → validity → analytical → clinical → PER
- Three pillars planned separately
- Intended purpose written to claim level
- Criteria derived from state of the art
- Literature method reproducible
- PMPF planned from the gaps
Deliverables
Performance Evaluation Plan Deliverables
The three pillars address separate questions, and plans that combine them are a frequent source of IVDR findings.
Example from a planScientific validity concerns biology rather than your device. Companies with strong analytical data often under-evidence it because the association seems widely accepted.
Example from an analytical performance sectionThe criteria are derived from the state of the art and the intended use. Criteria set after the validation runs will be met by design and do not demonstrate performance.
Example from a clinical performance sectionPredictive values depend on prevalence in the tested population. A claim generated in a high-prevalence cohort and applied to screening will be raised as a finding.
Example from a gap analysisA plan that shows no gaps often has criteria written to fit the data. Assessors generally view a clearly stated gap with a PMPF route more favourably than a plan with no gaps identified.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Performance Evaluation Plan Regulatory and Quality Standards
IVDR structures performance evaluation differently from MDR clinical evaluation, and the main difference is the three pillars.
In Vitro Diagnostic Regulation (Annex XIII)
Performance evaluation built on three pillars — scientific validity, analytical performance and clinical performance — each evidenced separately and each feeding the performance evaluation report.
Clinical evidence for IVDs (MDCG guidance)
Guidance on the general principles of clinical evidence for in vitro diagnostic medical devices: scientific validity, analytical performance and clinical performance, and how each is demonstrated in the performance evaluation.
PRISMA 2020 (literature methodology)
The search and screening method behind a defensible performance evaluation, which allows an assessor to reproduce your literature review rather than take it on trust.
Quality management (cert. H3CR9TCU20251212INDQM10N)
How the work is run, recorded 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 Plan
We define the intended purpose first, then plan each pillar against the claims that purpose makes.
Intended purpose
We state the analyte, function, specimen type, population, user and testing environment separately, because each one defines a different part of the evidence.
Scientific validity
We specify the evidence route for the association between analyte and condition, drawing on literature, guidelines and consensus rather than your own assay data.
Analytical and clinical performance
We set the study designs, parameters and acceptance criteria for each, and make the population and specimen requirements explicit.
Evidence Gaps and PMPF Planning
Where pre-market evidence cannot meet the criteria, we state the gap and define the post-market performance follow-up route.
Our Experts
Our Performance Evaluation Plan 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 Plan Writing Packages
Pricing depends on device classification, the novelty of the analyte and whether intended-use specimens are readily obtainable.
Performance evaluation plan
For manufacturers before evidence gathering begins
Quoted per projectOn class and analyte novelty
Delivery By scope
- ✓Intended purpose written to claim level
- ✓Scientific validity route specified
- ✓Analytical performance parameters and criteria
- ✓Clinical performance design and criteria
- ✓Literature method fixed
- ✓Gaps assigned to PMPF
For a novel analyte, most of the work lies in the scientific validity pillar. For a well-established analyte, this pillar is largely based on literature.
Deliverables Request a quotePlan and evaluation together
For a complete performance evaluation
Quoted per projectOn class and evidence state
Delivery By scope
- ✓Performance evaluation plan first
- ✓Scientific validity report
- ✓Analytical performance report
- ✓Clinical performance report
- ✓Performance evaluation report assembling all three
- ✓PMPF plan from the gaps
The three reports and the PER form one package. Splitting them across suppliers can introduce inconsistencies.
Deliverables Request a quotePlan review
For a plan written by another provider
Quoted per projectOn plan length and class
Delivery By scope
- ✓Assessed against Annex XIII Part A
- ✓Three pillars checked for genuine separation
- ✓Criteria tested for circularity
- ✓Population and prevalence assumptions checked
- ✓Findings reported by severity
The most common finding is a plan that treats scientific validity as an introduction rather than as an evidenced pillar.
Deliverables Request a quoteSend us your intended purpose, and we will tell you free of charge which of the three pillars will carry the main evidence burden for your assay.
FAQs
Performance Evaluation Plan FAQs
If your question is not answered here, ask an expert — no quote is required.
Scientific validity — is the analyte associated with the clinical condition. Analytical performance — does the assay measure the analyte correctly. Clinical performance — does the result do what you claim for the intended population.
IVDR Annex XIII requires each to be evidenced, and the performance evaluation report assembles all three.
Usually, for an established analyte. Peer-reviewed literature, clinical guidelines, consensus statements and proof-of-concept studies are all acceptable sources.
For a novel analyte or a novel association, scientific validity carries the most weight and is the pillar most likely to require your own evidence.
MDR clinical evaluation asks about clinical benefit and safety of a device acting on the patient. IVDR performance evaluation asks whether a test result is valid and clinically useful, which is a different chain of reasoning.
Reusing an MDR clinical evaluation plan structure for an IVD is a clear error, most visibly because the three pillars are absent.
On the performance evaluation cycle, and whenever PMPF findings change the evidence position or the state of the art moves.
The plan and report are updated together. A report updated against an unchanged plan is an inconsistency that an assessor will raise.
Related Services
Related IVD Performance Evaluation Services
The plan defines the performance evaluation, and the reports provide its evidence.
1PERFORMANCE EVALUATION REPORTSdownstream
Scientific validity reportThe first pillar. Performance evaluation reportAll three assembled.2POST-MARKET DOCUMENTATIONaddressing evidence gaps
PMS and device PSURArticles 83 to 86. PMCF and PMPFClosing the named gaps.3TECHNICAL DOCUMENTATIONalongside
Device risk managementISO 14971 file. GSPR checklistEvidenced line by line.Request a Free Intended Purpose and Evidence Burden Review
For most assays, one of the three pillars carries most of the evidence cost. We will tell you free of charge which one, so that you can plan the work accordingly.