Global Clinical Performance
Evaluation for
In Vitro Diagnostic (IVD)
Medical Devices

Bringing an IVD medical device to market requires more than analytical performance, it requires robust clinical evidence demonstrating that the device performs accurately and reliably in its intended-use population. Regulatory authorities, including CDSCO, US FDA, EU IVDR, MHRA, and other global agencies, expect scientifically sound clinical evidence to support regulatory approvals and market access.


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At CliniExperts Research Services, we support IVD manufacturers throughout the complete product lifecycle. As a specialized Contract Research Organization (CRO) operating in accordance with ISO 20916, ICH-GCP, and globally accepted regulatory standards, we generate high-quality Clinical Performance Evaluation (CPE) data to support global regulatory submissions.

Our integrated services cover scientific evidence development, clinical regulatory intelligence, pilot and pivotal clinical performance studies, AI-enabled diagnostic validation, new market access studies, post-market clinical evidence generation, Medical writing, Biostatistics, clinical data management, Clinical Operations and regulatory support.

Whether you are developing a molecular diagnostic, companion diagnostic, point-of-care test, AI-enabled IVD software, digital pathology solution, or a novel biomarker assay, we provide end-to-end scientific, regulatory, and clinical support to help you generate inspection-ready clinical evidence, achieve global regulatory approvals, and successfully commercialize your product.

Global IVD Evidence Lifecycle Framework

Global IVD Clinical Evidence Lifecycle Framework

1

Scientific Evidence & Clinical Regulatory Intelligence

Supporting Scientific Understanding and Regulatory Interpretation of Diagnostic Targets

This phase focuses on establishing the scientific and regulatory foundation required for the development of an IVD Medical Device. The activities performed under this stage support manufacturers in understanding the scientific validity of the diagnostic target, identifying applicable regulatory requirements, and planning an appropriate clinical evidence generation strategy.

Activities Performed

  • Systematic literature reviews of analytes, biomarkers, disease pathways, and intended clinical applications.
  • Scientific review and interpretation of published clinical and preclinical evidence to establish biomarker relevance, biological plausibility, and scientific validity.
  • Assessment of the association between analytes or biomarkers and the target disease to support the intended use of the IVD.
  • Clinical regulatory intelligence to identify applicable regulatory requirements and clinical evidence expectations for global markets, including IMDRF/GHTF, IVDR (EU), US FDA, MHRA, CDSCO, and other regulatory authorities.
  • Predicate device, comparator, and reference method mapping to support clinical development planning.
  • Clinical evidence gap assessment to identify additional evidence required for regulatory submissions.
  • Development of clinical evidence generation strategies, including study design recommendations, endpoint selection, target population, statistical considerations, and regulatory planning.
  • Review and synthesis of available non-clinical evidence to support assay performance and diagnostic concept justification.
2

Clinical Performance Evaluation (CPE)

Generating clinical evidence to demonstrate that an IVD medical device performs as intended in the target population and intended clinical setting in accordance with applicable global regulatory requirements.

A

Early Development Phase (Pilot Studies)

Feasibility, Optimization & Early Clinical Evidence

Studies conducted during the early development phase include:

  • Feasibility clinical performance studies to assess the initial performance of the IVD in the intended population.
  • Pilot diagnostic accuracy studies evaluating early clinical sensitivity, specificity, diagnostic accuracy, and assay performance.
  • Retrospective clinical performance studies using archived clinical specimens.
  • Prospective observational pilot studies to optimize study design, study procedures, and clinical workflows.
  • Assay optimization studies and reference method verification.
  • AI/ML clinical data collection, annotation, curation, and dataset development to support algorithm training and validation, where applicable.
B

Regulatory Approval Phase (Pivotal Studies)

Global Submission-Ready Clinical Evidence Generation

Studies conducted to support regulatory submissions include:

  • Prospective multicentre diagnostic clinical performance studies.
  • Cross-sectional diagnostic accuracy studies.
  • Method comparison and reference standard comparison studies.
  • Clinical performance studies evaluating clinical sensitivity, clinical specificity, diagnostic accuracy, positive and negative predictive values, reproducibility, and agreement with reference methods.
  • AI/ML validation studies to evaluate algorithm performance, robustness, and generalizability.
  • Interventional clinical performance studies (where applicable) to demonstrate clinical utility, clinical decision impact, patient management outcomes, healthcare outcomes, and the impact of diagnostic results on clinical decision-making.
C

New Market Access Studies

Population-Specific Clinical Evidence for Global Expansion

Studies conducted to support regulatory submissions and market expansion into new geographical regions include:

  • Multi-ethnic clinical performance studies to evaluate diagnostic performance across diverse ethnic populations.
  • Population-based clinical performance studies using prospective and real-world clinical data.
  • Prospective clinical performance studies to generate local clinical evidence required by country-specific regulatory authorities.
  • Retrospective clinical performance studies using archived clinical specimens for rapid evidence generation.
  • Bridging studies to demonstrate comparable clinical performance across different populations and healthcare settings.
  • AI/ML generalizability studies to assess algorithm performance across diverse demographic and clinical populations.
  • Clinical performance studies evaluating genotype, phenotype, ethnic, and epidemiological variability to demonstrate consistent diagnostic performance across intended-use populations.

These studies support country-specific regulatory submissions, expansion into new markets, and the generation of local clinical evidence while demonstrating the robustness and generalizability of the diagnostic system across different populations and healthcare environments.

D

Post-Market Evidence & Lifecycle Management

Continuous Performance Evaluation & Regulatory Compliance

Post-market studies and evidence generation activities include:

  • Real-World Evidence (RWE) studies to evaluate long-term diagnostic performance, clinical effectiveness, performance stability, and AI model performance under routine clinical practice.
  • Longitudinal follow-up studies to assess long-term diagnostic reliability, safety, and clinical outcomes.
  • Registry-based clinical performance studies (prospective or retrospective) to support population-level performance monitoring, utilization analysis, long-term outcome assessment, and regulatory reporting.
  • Post-Market Performance Follow-up (PMPF) studies to generate ongoing clinical evidence confirming the safety and performance of the IVD under real-world conditions.
  • Bridging (Comparability/Change Control) studies to demonstrate equivalent clinical performance following modifications to reagents, instruments, software, manufacturing processes, manufacturing sites, or AI/ML algorithm versions.
  • Clinical evidence generation to support intended-use expansion, product updates, software releases, and continued regulatory compliance throughout the product lifecycle.

Delivering End-to-End Global Clinical Evidence

From scientific validity assessment and regulatory strategy through clinical performance evaluation, regulatory approval, new market access, and post-market evidence generation, we support IVD manufacturers across the complete clinical evidence lifecycle.

Our services include :

End-to-end global clinical evidence

scientific evidence generation

Clinical regulatory strategy and Regulatory submissions

pilot and pivotal clinical performance studies

AI/ML clinical validation

real-world evidence generation

post-market performance follow-up

biostatistics

medical writing

clinical data management

project management

Clinical sites identification and management.

These integrated services help manufacturers generate high-quality clinical evidence to support global regulatory approvals and maintain compliance throughout the lifecycle of their IVD Medical Devices.

Why Partner With Us?

Global Compliance-
Driven Execution

Integrated CRO and clinical site ecosystem operating under ICH-GCP, ISO 20916, ISO 15189, and globally accepted regulatory expectations ensuring inspection-ready clinical evidence.

Frequently Asked Questions

What is Medical Device Form MD-24?

Medical Device Form MD 24 is an application form to get the grant or permission to conduct a medical device clinical study of a new in-vitro diagnostic kit.

The medical device clinical study must be initiated within one calendar year of receiving the permission. If permission is not granted, it will need to be approved in advance. The sponsor should submit an annual status report on the study to Central Licensing Authority. If the investigation ends, it should also be reported within thirty days.

The permission to conduct clinical performance evaluation for a new in vitro diagnostic medical device is granted in Form MD-25 by the Central Licensing Authority.

Any medical device or new in vitro diagnostic medical device imported or manufactured, for the purpose of clinical investigation or clinical performance evaluation, test, evaluation, demonstration and training, shall be kept in containers bearing labels, indicating the name of the product or code number, batch or lot number, serial number wherever applicable, date of manufacture, use before date, storage conditions, name and address of the manufacturer, and the purpose for which it has been manufactured.

Clinical performance evaluation in India are typically only required for risky IVD (Class B, Class C and Class D) without predicates and may also be required for Class A IVD’s.

IVD Clinical performance evaluation is the systematic performance assessment of an in vitro diagnostic kit using a specimen taken from humans to evaluate its performance. IVD Clinical investigation is the ability of the diagnostic kit to perform its intended function as claimed by the manufacturer. It includes the analytic and, where applicable, the clinical performance that supports the intended purpose.


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