Introduction
In vitro diagnostic (IVD) medical devices play a pivotal role in modern healthcare by enabling disease diagnosis, screening and monitoring. These products must meet rigorous performance criteria to ensure accuracy, reliability, and safety. Rather than clinical evaluations that are required for most medical devices, IVDs must undergo performance evaluations to ensure they meet performance and safety criteria for regulatory compliance and stakeholder expectations.
This article explores the essential components of IVD performance evaluations, international regulatory frameworks, and practical guidance to help manufacturers navigate this complex process.
What is a performance evaluation?
The EU In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 defines performance evaluation as:
“An assessment and analysis of data to establish or verify the scientific validity, analytical performance and clinical performance of a device.”
This evaluation ensures the device accurately detects or measures the correct analyte and produces reliable results across intended uses and populations.
Performance evaluation is not a one-time activity. It is part of a continuous lifecycle process that includes pre-market development and post-market surveillance.
Key components of a performance evaluation
Scientific validity refers to the demonstrated association between an analyte (the substance being measured) and a specific clinical condition or physiological state. It establishes that the analyte’s presence, absence, or concentration is meaningfully linked to the health condition the IVD is intended to detect, diagnose, or monitor. Scientific validity is typically supported by published literature, clinical guidelines, or well-designed studies, and it provides the foundational rationale for developing and using the IVD test. Scientific validity should be supported by:
- Literature reviews
- Clinical guidelines
- Epidemiological evidence
A common challenge in IVD performance evaluation is conducting an inadequate literature search, which can result in missing critical evidence or using low-quality data; this can be avoided by applying a systematic approach, such as following PRISMA guidelines, and carefully documenting search strategies. Another pitfall is over-reliance on surrogate endpoints without sufficient validation—ensuring that any biomarker or analyte used has a direct, clinically validated connection to meaningful patient outcomes to support robust performance claims is essential. Biomarker qualification studies using recognised evidentiary frameworks help to ensure this:
- FDA Biomarker Qualification Framework: A structured approach defined by the FDA’s Centre for Drug Evaluation and Research (CDER) that outlines the types of evidence needed to support biomarker qualification for a specific context of use, as part of the FDA’s Drug Development Tool (DDT) program.
- EMA Biomarker Qualification Procedure: A formal process under the European Medicines Agency that provides scientific advice and qualification opinions on biomarkers, describing the required data and validation evidence for use in regulatory submissions.
- BEST (Biomarkers, EndpointS, and other Tools) Resource: Developed by the FDA and NIH, this framework defines biomarker types and acceptable evidence for their use, helping to harmonise terminology and expectations for biomarker qualification.
These frameworks guide developers on the level and type of data needed to demonstrate that a biomarker is fit for its intended purpose, supporting regulatory acceptance and broader stakeholder confidence.
Analytical performance refers to the device’s technical ability to detect or measure the analyte with precision and accuracy. Key parameters include:
- Accuracy (Trueness and Precision)
- Analytical Sensitivity (Limit of Detection, Limit of Quantification, Dynamic Range)
- Analytical Specificity (Interferences, cross-reactivity)
- Linearity and Measuring Range
- Repeatability and Reproducibility
- Robustness and Stability
- Carry-over effects
Analytical performance must be verified under suitable pre-analytical conditions, including sample types, storage conditions, and operator variability.
Designing analytical performance studies can be challenging for new IVD innovators.
- Inappropriate comparator selection: Using a non-standard or low-quality reference method can undermine the validity of accuracy claims. Select well-established, accepted comparators (gold standards or appropriate clinical reference methods).
- Underpowered studies: Small or unrepresentative sample sizes may fail to demonstrate statistically robust performance. Failing to include relevant subpopulations (e.g. disease stages, interfering conditions) limits generalisability. Ensure a representative and sufficient sample size, covering relevant populations, matrix types, and conditions that reflect intended use.
Engage stakeholders, including regulators and customers, early (e.g. pre-submission meetings) to confirm study design meets expectations in target markets. Consult applicable standards and guidance (e.g. ISO 15189, CLSI guidelines, MDCG IVD guidance) to align study design with best practices.
Clinical performance studies demonstrate how well the test result correlates with the clinical condition or outcome. Key metrics include:
- Sensitivity and Specificity
- Positive Predictive Value (PPV) / Negative Predictive Value (NPV)
- Receiver Operating Characteristic (ROC) curves
- Likelihood Ratios
Clinical performance studies may be prospective or retrospective, but they must reflect real-world usage and comply with Good Clinical Practice (GCP). The challenges outlined in the Analytical Performance section also apply to designing clinical performance evaluations.
Regulatory Frameworks: EU and US Perspectives
The IVDR (EU) 2017/746, which fully replaced the In Vitro Diagnostic Medical Device Directive (IVDD) in May 2022, imposes significantly more stringent requirements for performance evaluations. Under IVDR a Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER) are required and must include:
- Scientific validity: Demonstrates the association of the analyte with a clinical condition.
- Analytical performance: Accuracy, precision, specificity, sensitivity, linearity, etc.
- Clinical performance: The device’s ability to yield results correlated with a clinical condition or physiological state.
- Benefit-risk conclusions
- PMPF (Post-Market Performance Follow-up) plan: Manufacturers must update the PER periodically, especially for high-risk devices (at least annually for Class D).
In addition:
- Class C and D devices require Notified Body involvement and, in many cases, expert panel consultation.
- Manufacturers must maintain a PEP and a PER as part of the technical documentation.
- Annex XIII of IVDR outlines detailed requirements for performance evaluation and post-market performance follow-up (PMPF).
In the US, the FDA regulates IVDs as medical devices under 21 CFR Part 809. Depending on risk classification, FDA clearance may be required through:
- 510(k) (Premarket Notification)
- De Novo classification request
- Premarket Approval (PMA)
FDA typically requires:
- Analytical validation data for all devices
- Clinical performance data for moderate and high-risk tests
- Labelling compliance with 21 CFR 809.10
The FDA also encourages using relevant standards and evidence-based study designs (e.g., prospective clinical trials) for novel tests.
ISO 20916:2019 – In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice:
- ISO 20916:2019 provides a structured framework for planning, conducting, recording, and reporting clinical performance studies for IVDs. It applies to prospective, interventional, or observational studies conducted using human specimens, particularly when intended for regulatory submissions.
- This standard extends ICH-GCP principles to diagnostic testing that does not involve direct intervention in patients. It emphasises study transparency, ethical oversight, and data integrity. The standard also provides for study planning, roles and responsibilities, study execution, and reporting.
- ISO 20916 is particularly relevant for compliance with Annex XIII of the EU IVDR, which mandates GCP for clinical performance studies. Regulatory bodies, including Notified Bodies and the FDA may reference ISO 20916 when reviewing IVDs with novel claims or higher risk classifications.
CLSI Guidelines – Analytical Validation and Laboratory Best Practices:
The Clinical and Laboratory Standards Institute (CLSI) is an internationally recognised non-profit organisation that produces consensus-based laboratory standards. Relevant standards include:
- EP05: Evaluation of Precision Performance of Quantitative Measurement Methods – covers repeatability and reproducibility
- EP06: Evaluation of Linearity – addresses linear range and method comparison
- EP07: Interference Testing in Clinical Chemistry – identifies endogenous and exogenous interferences
- EP09: Method Comparison and Bias Estimation Using Patient Samples – comparison to predicate or gold standard
- EP17: Detection Capability – defines Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
- EP28: Defining, Establishing, and Verifying Reference Intervals – guides creation of reference ranges by population
CLSI Guidelines provide statistically robust methodologies for validating IVD performance claims. They help standardise the approach to establishing critical analytical parameters such as precision, specificity, and measuring range. The FDA often references them in guidance for 510(k) and PMA submissions, and Notified Bodies and Health Authorities accept them as best practice documentation.
ISO 15189:2022 – Medical Laboratories – Requirements for Quality and Competence:
- ISO 15189 specifies requirements for the quality and competence of medical laboratories, including those that perform testing using IVD medical devices. Laboratories performing clinical performance studies or post-market performance follow-up (PMPF) must operate under ISO 15189 or equivalent.
- Notified Bodies often require evidence that performance studies or real-world data were generated in accredited laboratories. This standard is critical for reference laboratories supplying comparator methods in clinical validation studies.
- Key provisions in ISO 15189 include Quality Management System (QMS) requirements, risk management, technical lab requirements (personnel, equipment calibration and maintenance, validation of test methods, handling of test samples and reagents and traceability of results) and pre- and post-analytical processes.
Common Pitfalls and How to Avoid Them
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Poorly defined intended use: If the intended use is vague or incomplete, the study design and evidence may fail to meet regulatory requirements. Tip: Clearly define the intended use at the start and design studies that directly support the specific performance claims (e.g., sensitivity, specificity, cut-off validation).
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Insufficient regulatory alignment: Failing to align with regional regulatory expectations can result in costly delays or the need to repeat studies. Tip: Engage with regulators early—through pre-submission meetings or consultations—to ensure your study design meets the expectations of each target market.
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Data integrity and documentation gaps: Weak data management, poor traceability, or incomplete documentation can undermine the credibility of your findings. Tip: Involve biostatisticians during study planning and implement a robust data management plan to ensure high-quality, traceable data and audit-ready documentation.
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Neglecting post-market data: Overlooking the need for post-market data collection weakens long-term performance claims and market confidence. Tip: Design and execute a strong PMPF plan to gather real-world evidence that supports ongoing safety and performance.
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Studies designed solely for regulatory approval: Several HTA organisations and payers publish guidelines or frameworks that, while not regulatory, strongly influence how IVD performance evaluations or clinical investigations should be designed to demonstrate value for reimbursement, coverage, or adoption. These bodies typically require evidence beyond analytical validity, including the impact on clinical decision-making, patient outcomes and cost-effectiveness. Early consultation with HTA bodies (where available) or use of joint scientific advice (e.g. EMA-EUnetHTA, NICE-UKCA) can help align study design with both regulatory and reimbursement requirements.
Conclusion
Performance evaluations are central to ensuring the safety, reliability, and clinical utility of IVD medical devices. With heightened regulatory expectations under IVDR and a globally harmonised push toward evidence-based validation, manufacturers must adopt a rigorous, systematic, and lifecycle-oriented approach to performance evaluation.
By grounding evaluations in relevant standards (like ISO 20916 and CLSI guidelines), aligning with regional regulatory frameworks, and proactively planning for both pre- and post-market evidence generation, IVD developers can achieve regulatory compliance and instil confidence among clinicians, patients, and investors.
In a rapidly advancing diagnostic landscape, robust performance evaluation is no longer just a regulatory hurdle—it’s a strategic advantage.
Resources
This section contains the guidelines on clinical investigations provided by regulatory authorities. Some of these documents also contain guidance relevant to clinical evaluation.
European Union (EU): Medical Device Coordination Group (MDCG)
- MDCG 2022-2 – Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)
- MDCG 2022-9 – PMPF (Post-Market Performance Follow-up) under the IVDR
- MDCG 2022-10 – Guidance on safety reporting in performance studies
- MDCG 2022-12 – Guidance on harmonised administrative practices and alternative technical solutions for IVD performance studies in the absence of EUDAMED
- MDCG 2022-19 – Guidance on summary of safety and performance template (SSP) for class C and D IVDs- (helps summarize performance data for users)
United States of America (USA): Food and Drug Administration (FDA)
- Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
- Principles for Co-development of an In Vitro Companion Diagnostic Device with a Therapeutic Product
- In Vitro Companion Diagnostic Devices Guidance
- Recommendations for CLIA Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
- FDA Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions
- Design Considerations for Pivotal Clinical Investigations for Medical Devices
- Deciding When to Submit a 510(k) for a Change to an Existing Device
Canada: Health Canada
- Guidance Document: Applications for Medical Device Licences – Diagnostic Devices
- Guidance Document: Investigational Testing Authorization for Medical Devices
- Guidance for Industry: Management of Applications for Medical Device Licences and Investigational Testing Authorizations
- Guidance on Supporting Evidence to be Provided for New and Amended Licence Applications for Class III and Class IV Medical Devices
- Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations
United Kingdom (U.K.): Medicines and Healthcare products Regulatory Agency (MHRA)
- Guidance: In vitro diagnostic medical devices (IVDs)
- Guidance: Clinical investigations of medical devices
Australia: Therapeutic Goods Administration (TGA)
- Regulation of in vitro diagnostic medical devices (IVDs)
- Clinical evidence guidelines: Medical devices (including IVDs)
- Australian regulatory guidelines for medical devices (ARGMD)
- Conformity assessment procedures
- Essential principles checklist
International Medical Device Regulators Forum (IMDRF)
- IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
- IMDRF Software as a Medical Device (SaMD): Clinical Evaluation
- IMDRF Definitions for IVD Medical Device Regulatory Guidance
Guidelines on Gathering Clinical Evidence from Payers & HTA Organisations
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EUnetHTA: Guidelines on the evidence required for diagnostic and screening technologies. These outline evidence requirements for relative effectiveness, accuracy, and clinical utility of diagnostics for HTA across Europe.
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NICE Diagnostic Assessment Programme Methods Guide (UK). Specifies expectations for evidence on test accuracy, clinical impact, cost-effectiveness, and patient outcomes for IVDs seeking NICE endorsement.
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G-BA / IQWiG (Germany) – Methods for evaluating diagnostic tests. Focuses on linking test performance to patient-relevant outcomes; accuracy alone is not sufficient for reimbursement decisions.
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CADTH Diagnostic Imaging and Testing HTA Methods (Canada). Requires demonstration of how diagnostic performance translates into better patient management and outcomes.
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MSAC Guidelines (Australia). Stipulates that diagnostic tests must show clinical utility — that using the test leads to improved health outcomes or cost savings.
European Union (EU):
in vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746:
- Article 56 – Performance evaluation and performance studies
- Article 57 – Performance studies
- Article 58 – Performance studies in emergency situations
- Articles 59-66 – Procedures for performance study applications, modifications, reporting, and supervision
- Annex I (General Safety and Performance Requirements) – Especially sections on analytical and clinical performance
- Annex XIII – Performance evaluation and performance studies (Part A: Performance evaluation plan and report, Part B: PMPF plan and report)
- Annex XIV – Interventional and other performance studies (study design, conduct, and reporting requirements)
United States of America (USA):
Food and Drug Administration (FDA), Federal Food, Drug, and Cosmetic Act (FD&C Act):
- 21 CFR 809.10 – Labeling for in vitro diagnostic products
- 21 CFR 807 Subpart E – Premarket Notification Procedures (510(k))
- 21 CFR 814 – Premarket Approval of Medical Devices
Canada
Medical Devices Regulations (SOR/98-282)
- Part 1 for general requirements
- Part 1.1 for investigational testing
United Kingdom
UK Medical Devices Regulations 2002:
- Part IV for in vitro diagnostic medical devices
- Part II, Regulation 43 – Performance evaluation for IVDs. Mandates performance evaluation rather than clinical evaluation for in vitro diagnostic devices
- Part II, Regulation 56 – Fee and notification rules for clinical investigations. Details MHRA fee structure and lawful notification timing for clinical investigations
- Regulation 16 – General requirements (including clinical investigation reporting). Covers notification, approval, and reporting obligations for clinical investigations
- Regulation 29 – Duties of manufacturers for clinical investigations. Defines manufacturer responsibilities for design, safety, ethical approval, and reporting
- Annex X (of Part II, Schedule 2A) – Clinical Evaluation Report (CER) requirements. Specifies the need for systematic collection and assessment of clinical data from literature, equivalence, and investigations
Australia
Therapeutic Goods (Medical Devices) Regulations 2002
International Standards:
- ISO 20916:2019 – In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
- ISO 15189: Medical laboratories — Requirements for quality and competence
- ISO 17511: Requirements for establishing metrological traceability of values assigned to calibrators and control materials
- ISO 18113 (Parts 1-5): In vitro diagnostic medical devices — Information supplied by the manufacturer
- ISO 23640: In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
CLSI Guidelines – Analytical Validation and Laboratory Best Practices:
- EP05: Evaluation of Precision Performance of Quantitative Measurement Methods – covers repeatability and reproducibility
- EP06: Evaluation of Linearity – addresses linear range and method comparison
- EP07: Interference Testing in Clinical Chemistry – identifies endogenous and exogenous interferences
- EP09: Method Comparison and Bias Estimation Using Patient Samples – comparison to predicate or gold standard
- EP17: Detection Capability – defines Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
- EP28: Defining, Establishing, and Verifying Reference Intervals – guides creation of reference ranges by population
510(k) Clearance: A premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA (Premarket Approval).
Acceptance Criteria: The predefined standards and specifications that a device must meet during testing and evaluation to be deemed suitable for its intended use and to comply with regulatory requirements.
Analytical Sensitivity: The ability of a test to detect even small amounts of a substance in a sample.
Analytical Specificity: The ability of a test to distinguish between the substance of interest and other substances that might be present in the sample.
Antigen: Any substance that the immune system can recognise and react against. Antigens are typically proteins or polysaccharides on the surface of pathogens, such as bacteria and viruses, but can also include other substances like toxins or allergens.
Assay: A laboratory procedure measuring the presence, amount, or activity of a specific substance. Also see Test.
Benefit-Risk Analysis: The comparison of a medical device’s benefits to its associated risks, often used in regulatory decision-making.
Biomarker: A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.
Biomarker Discovery: The process of identifying new biomarkers, which are biological molecules that indicate a particular disease state or condition.
Biomarker Validation: The process of confirming that a biomarker is a reliable indicator of a disease state or condition, often involving clinical trials and other studies to verify its efficacy and accuracy.
Clinical Context: The specific medical conditions, patient populations, and healthcare settings in which a device is intended to be used, influencing its design, functionality, and regulatory requirements.
Clinical Evaluation: A methodologically sound ongoing procedure to collect, appraise, and analyse clinical data about a medical device and to verify its safety and performance, including its clinical benefits. Also see Clinical Investigation.
Clinical Investigation: Any systematic investigation or study in or on one or more human subjects undertaken to assess the safety or performance of a medical device.
Clinical Laboratory Improvement Amendments (CLIA): Regulations in the United States governing laboratory testing to ensure quality and accuracy.
Clinical Setting: A healthcare environment where patient care is provided, such as hospitals, clinics, or private practices, where medical professionals diagnose and treat patients.
Companion Diagnostic: A diagnostic test used as a companion to a therapeutic drug to determine its applicability to a specific person.
Compliance: Adherence to regulations, standards, and guidelines set forth by regulatory authorities.
Conformity Assessment: A process used to determine whether a product, service, system, or entity meets specified standards, regulations, or requirements.
Diagnostic: Pertaining to the identification of a disease or condition. Diagnostic tests and procedures are used to determine the cause of symptoms or to confirm the presence of a particular disorder.
Dynamic Range: The range over which a test can measure an analyte with acceptable accuracy and precision, extending from the LOQ to the upper limit of quantification.
False Positive: A test result indicating that a person has a disease or condition when they do not.
False Negative: A test result indicating that a person does not have a disease or condition when they do.
Endpoint: The measurable result at the end of a study, including types such as:
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Clinical Endpoint: A precisely defined and measurable outcome used to determine the effect of an intervention.
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Performance Endpoint: A measure of how well the medical device achieves its intended purpose.
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Primary Endpoint: The main result that is measured at the end of a study to see if the treatment worked (e.g., the change in a clinical measurement from baseline to the end of the study).
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Safety Endpoint: A measure of the frequency and severity of adverse events experienced by participants during a clinical trial.
Equivalency: Demonstrating that a new device is as safe and effective as an already marketed device by comparing its technical and functional characteristics.
Ethics Committee (Institutional Review Board - IRB): An independent group that reviews and monitors the ethical aspects of a clinical trial.
Good Clinical Practice (GCP): An international quality standard provided by the International Conference on Harmonisation (ICH) for the conduct of clinical trials involving human subjects.
Health Technology Assessment (HTA): A systematic evaluation of the properties, effects, and impacts of health technology, such as medical interventions, pharmaceuticals or medical devices, to inform healthcare decision-making.
In Vitro Diagnostics (IVD): Tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections.
IVD Directive (IVDD): European regulation for the safety and performance of in vitro diagnostic medical devices.
IVD Regulation (IVDR): New regulation in the European Union that updates and replaces the IVDD, aimed at ensuring the safety and performance of IVD medical devices.
Indication of Use: A concise statement specifying the medical conditions or purposes for which the medical device is intended to be used, as approved by regulatory authorities.
Informed Consent: The process through which a participant voluntarily confirms their willingness to participate in a study after being informed of all study aspects relevant to their decision to participate.
Instructions for Use (IFU): The document provided by the manufacturer that includes essential information on a medical device’s intended purpose, proper handling, operation, maintenance, and safety precautions for users.
Intended purpose: The use for which a medical device is intended according to the information provided by the manufacturer on the labelling, in the instructions for use (IFU), or in promotional materials. This may also be referred to as the Intended Use in some jurisdictions. Also see Indication of Use.
International Medical Device Regulators Forum (IMDRF): A global regulatory collaboration focused on harmonising medical device regulations to facilitate patient access to safe and effective devices. This organisation was formerly the Global Harmonization Task Force (GHTF).
Investigator: An individual who conducts a clinical investigation and is responsible for ensuring the study’s integrity and participants’ welfare. Also see Clinical Investigation.
Investigational Device Exemption (IDE): An exemption that allows a medical device to be used in a clinical study to collect safety and effectiveness data, typically required before a device can be marketed.
in vitro Diagnostics (IVD): Medical tests conducted on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections outside the body.
Labelling: The label on a medical device and all descriptive and informational literature associated with the device. Also see Instructions for Use (IFU)
Limit of Detection (LOD): The lowest amount of an analyte that a test can reliably detect but not necessarily quantify.
Limit of Quantification (LOQ): The lowest amount of an analyte that can be quantitatively detected with suitable precision and accuracy.
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Notified Body (NB): An organisation designated by a country authority to assess the conformity of certain products before being placed on the market, ensuring they meet applicable regulatory requirements and standards.
Payer: An entity or organisation, such as an insurance company or government agency, responsible for reimbursing or funding healthcare expenses related to using health technologies.
Performance Evaluation: A systematic assessment of an IVD’s analytical and clinical performance, demonstrating that the device achieves its intended purpose and generates results suitable for its specified medical use.
Post-Analytical: The phase in IVD that includes all activities following the analysis of a sample, such as result interpretation, reporting, storage of results, and data management.
Post-Market Surveillance (PMS): The proactive collection and review of experiences and data related to a device after it has been released onto the market to ensure continued safety and performance.
Predicate Device: An existing on-market device that provides a basis for comparison or reference in demonstrating substantial equivalence for regulatory purposes.
Pre-analytical: The phase in in vitro diagnostics (IVD) that encompasses all processes before the actual analysis of a sample, including sample collection, handling, transport, storage, and preparation.
Precision: The degree to which repeated measurements under unchanged conditions show the same results. It reflects the reproducibility of the test results.
Real World Evidence: Clinical evidence regarding the use and potential benefits or risks of a medical product derived from real-world data (RWD) sources outside traditional clinical trials.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.
Reimbursement: The process of receiving payment from insurers, government health programs, or healthcare facilities for the use of medical devices in patient care.
Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.
Sample: A portion of material, such as blood, urine, or tissue, taken from a patient for testing or analysis to provide information about their health.
Sample Type: The specific kind of sample collected for analysis, such as blood, urine, saliva, or tissue, which can affect the type of tests that can be performed and the accuracy of the results.
Scientific Validity: The extent to which the results of a test or study accurately reflect or measure the concept or phenomenon being studied. In diagnostics, scientific validity refers to the ability of a test to correctly identify or measure a health condition, based on sound scientific evidence and methodology.
Screening: The process of testing individuals who do not yet have symptoms of a disease to detect the condition at an early stage. Screening aims to identify diseases early when they are more likely to be treatable.
Sensitivity: The ability of a diagnostic test to correctly identify individuals with a disease.
Specificity: The ability of a diagnostic test to correctly identify individuals without a disease.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
State-of-the-art (SotA): The current knowledge or good practice acceptable in the medical devices industry.
Study Protocol: A document that describes the objectives, design, methodology, statistical considerations, and organisation of a clinical study.
Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.
Traceability: The ability to verify an item’s history, location, or application by means of documented recorded identification.
User: Any individual who operates or interacts with a medical device, including healthcare professionals, patients, and caregivers.
Vigilance: The systematic process of monitoring, evaluating, and responding to safety issues and adverse events related to medical devices to ensure ongoing safety and compliance with regulatory standards.