Introduction

Performance Evaluation Report (PER): For in-vitro diagnostic medical devices, a Performance Evaluation Report (PER) is essential. This report assesses and analyzes data to confirm the scientific validity, analytical, and where applicable, clinical performance of a device. The IVDR (Regulation (EU) 2017/746) superseded Directive 98/79/EC and became fully enforceable on May 26, 2022.

Purpose: Harmonise rules for placing IVDs on the EU market; raise safety, performance, transparency; ensure performance evaluation, clinical evidence, risk management, post‑market surveillance etc. 

Applies to device types: reagents, kits, instruments, software etc. intended for in vitro examination of human specimens to provide diagnostic information.

Device Overview and Intended Purpose

Definitions: Article 2 (12) of IVDR ‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation;  

The device overview in the technical documentation (Annex II) must include full specification, intended user(s), specimen type(s), analyte(s), target population, performance claims etc. 

The Annex I, Sections 1 to 9 intended purpose drives everything: what scientific validity must be shown, what clinical performance must be demonstrated, what risks exist etc.

Scientific Validity Assessment (SVR)

What is Scientific Validity? 

Defined in Article 2(38) “ It means the association of an analyte with a clinical condition or a physiological state.” Annex XIII Part A (section 1.2.1) lays out how scientific validity must be demonstrated: via peer‑reviewed literature, consensus expert opinion, results of proof‑of‑concept studies, clinical performance studies etc. Must perform a systematic literature review: state search strategy, inclusion/exclusion criteria, assessment of data suitability, identify gaps and, where needed, generate new data. Document in a Scientific Validity Report (SVR), which becomes part of technical documentation.
References: Article 56: Performance evaluation and clinical evidence (especially (3)(a)) and MDCG 2022‑2 (Guidance on clinical evidence) for how to interpret scientific validity in practice.

Analytical Performance Evaluation (APR)

• Analytical performance concerns the ability of the device to correctly detect or measure the analyte. Definition: Article 2(40) of IVDR.

• Key parameters required (Annex I, particularly Section 9.1): sensitivity, specificity, limit of detection/quantitation, linearity, trueness, precision (repeatability & reproducibility), measurement range, interference, stability etc. 

If certain analytical performance aspects cannot be met (e.g., no reference materials, etc.), omission must be justified.

References: Annex XIII, Part A, Section 1.2.2: Demonstration of analytical performance and Article 56 (3)(b) about what must be shown under performance evaluation.

Clinical Performance Evaluation (CPR)

• Definition: Article 2(41) – ability of a device to yield results that are correlated with a clinical condition or physiological or pathological state, under intended use. 

• Annex XIII, Part A, Section 1.2.3: Clinical performance studies are needed unless sufficient data from literature or equivalent devices justify otherwise. 

Study design: must follow the clinical performance study plan in Annex XIII, define target population, comparator, endpoints (diagnostic sensitivity, specificity, predictive values etc). Ethical requirements, monitoring, statistical considerations.

References: Article 56 (3)(c) , Article 56(4): requirement for clinical performance studies unless justified otherwise and MDCG guidance on clinical evidence (e.g. MDCG 2022‑2)

Risk Management and Benefit–Risk Analysis

• IVDR requires a risk management system. Article 10 and Annex I (Section 3) require manufacturers to identify risks, estimate and evaluate them, control and monitor residual risks. 

• Risk management must be aligned with performance evaluation: risks identified must be addressed in the performance studies (SVR, APR, CPR), and post‑market follow‑up.

• Benefit‑risk determination: as part of performance evaluation, confirm that the intended clinical benefit(s) outweigh the residual risks, using evidence and state‑of‑the‑art comparison. 

Post‑Market Performance Follow‑Up (PMPF)

• PMPF is a continuous process (Part B of Annex XIII) that updates the performance evaluation using data from actual use after placing it in the market. 

• Must be included in the manufacturer’s post‑market surveillance plan (Article 79) and align with risk management. 

• For higher risk (Class C and D), updates of performance evaluation reports (PER) and summaries of safety & performance must be at least annually.

• Article 56(6): performance evaluation and documentation shall be updated throughout the lifecycle, using data from PMPF and PMS (post‑market surveillance)

Systematic Literature Review Process

• Required as part of Scientific Validity: systematic search of peer‑reviewed literature, databases, inclusion/exclusion criteria, evaluation of relevance and quality.

• Annex XIII, Part A, Section 1.2 (part of “Demonstration of scientific validity and analytical / clinical performance”) requires identifying through systematic scientific literature review available data.

• Article 56: requires performance evaluation to consider all data, including literature.

• Documented in a Literature Search Protocol (LSP) and Literature Search Report (LSR) which feed into SVR. Industry sources emphasise this.

State‑of‑the‑Art 

• Article 56(3): Clinical evidence must demonstrate that intended clinical benefit(s) will be achieved “by reference to the state of the art in medicine.

• Annex XIII, Part A, Section 1.1: PEP must include description of state of the art, existing devices, relevant standards, CS (common specifications), guidance.

• General Safety & Performance Requirements in Annex I, include performance in view of recognized state of the art.

PER Requirement

• Intended application or purpose of the device

• Useful information, restrictions, and contraindications

• Supported by the performance assessment, the General Safety and Performance Requirements (GSPR)

• A list of the device's recorded evidence

• Performance requirements for the IVD

• An explanation of the state of the art at the moment

• Parameters for benefit-risk ratio

• A list of the analytical tests conducted and the benchmarks utilised

• Envisioned target patient populations

• To be utilised markers or analytes

• Fundamental principles for software decision-making (if applicable)

Format of PER

Product Name / Version / Basic UDI-DI / UMDNS / GMDN

• Product Name & Version: Identify the exact trade name and model/version.

• Basic UDI-DI: Unique identification code as per IVDR Article 24.

• UMDNS & GMDN Codes: Global nomenclature codes for device classification.

Relevant Documents

List cross-references to controlled documents:

• SOP for Performance Evaluation

• Performance Evaluation Plan (PEP)

• Risk Management File

• IFU and labeling

• Clinical evidence documents.

Intended Use

Copy the approved intended purpose text (as per Annex I, Chapter I).
It must clearly describe:

• Target population/patient group

• Specimen type and test principle

• Clinical conditions/indications

• User profile (professional/lab/home use).

Risk Analysis

Provide a summary of the Risk Management Report (ISO 14971) showing:

• Identified hazards (biological, analytical, clinical)

• Mitigation measures

• Residual risk acceptability in relation to benefits.

Medical Context and State of the Art

• Medical Context

Describe the clinical need and disease/condition addressed by the device, citing prevalence, epidemiology, and diagnostic pathways.

• State of the Art

Summarize current scientific and clinical knowledge, alternative diagnostic methods, and relevant guidelines to establish the benchmark for device performance.

Scientific Validity

• Literature Search Methods

Describe search strategy, inclusion/exclusion criteria, and databases used to confirm the scientific link between the analyte/marker and the intended clinical condition.

• Literature Search Results

Provide a concise summary of key publications demonstrating scientific validity.

• Literature Search Conclusion

State the conclusion that the analyte/marker relationship is scientifically valid, fulfilling IVDR Annex XIII, Part A.

Analytical Performance

• Methods

Summarize study designs, reference methods, and protocols used to verify analytical characteristics (e.g., accuracy, precision, sensitivity, specificity, stability, limit of detection).

• Results

Present key outcomes demonstrating that the device meets its claimed analytical performance and GSPRs.

Clinical Performance

• Methods

Outline clinical performance study design or justification for using existing clinical evidence. Include details on sample population, endpoints, and statistical analysis.

Results

Summarize findings on diagnostic sensitivity, specificity, predictive values, and clinical utility as per IVDR Annex XIII.

Overall Summary

Provide an overall assessment confirming that:

• Scientific validity, analytical performance, and clinical performance requirements are met (Annex XIII, Part A).

• Device achieves intended purpose and complies with Annex I GSPRs.

• Benefits outweigh residual risks.

Performance Evaluation Updates Under IVDR: What Class C & D Manufacturers Must Know

The performance evaluation and related documents must be kept up to date throughout the device’s entire life cycle. This should include any new data collected through:

The manufacturer’s Post-Market Performance Follow-up (PMPF) plan, and

The Post-Market Surveillance (PMS) plan, as required by IVDR.

For Class C and Class D devices, the Performance Evaluation Report (PER) must be updated at least once a year, or sooner if needed based on new data Safety and Performance (SSP) as required under Article 29(1) should be updated as soon as necessary, especially if there are important changes to the device’s safety or performance.

Conclusion

• Must assemble Performance Evaluation Report (PER) (Annex XIII, Part A, section 1.3.2) which includes SVR, APR, CPR, plus state‑of‑art, benefit‑risk conclusions, method justifications etc.

• Must ensure technical documentation (Annex II) includes all this and supports conformity with General Safety & Performance Requirements (Annex I). Notified Body review: they assess the performance evaluation, risk management, PMPF plan, method justifications etc.

• Lifecycle approach: evidence must be updated over time (PMPF), adverse event reporting, field safety corrective actions when needed.