ISO/DIS 18969: Establishing a Global, Methodological Reference for Clinical Evaluation
The clinical evaluation of medical devices constitutes a fundamental element of regulatory conformity assessment across global markets. Regulatory frameworks such as Regulation (EU) 2017/745 for Medical Devices (MDR) establish legally binding requirements for clinical evaluation; however, they do not prescribe a fully harmonized and reproducible methodology for conducting, documenting, and maintaining clinical evaluations throughout the device lifecycle.
As a result, manufacturers and Notified Bodies have faced divergent interpretations and inconsistent expectations regarding the structure, depth, and sequencing of clinical evaluation activities.
The draft international standard ISO/DIS 18969- Clinical Evaluation for Medical Devices has been developed to provide a comprehensive methodological framework for clinical evaluation that is independent of regional regulatory systems.
ISO/DIS 18969 as the Emerging Global Reference Standard for Clinical Evaluation
A globally harmonised framework for clinical evaluation
ISO/DIS 18969 establishes a complete international standard describing the clinical evaluation process from planning through to lifecycle maintenance. Unlike regional regulations or guidance documents, the standard is not limited to a specific legal framework and is therefore applicable across global markets. It defines a structured and reproducible methodology covering planning, identification, appraisal, analysis of data , overall assessment, benefit–risk evaluation, reporting, and continuous updating.
For manufacturers operating internationally, this provides a consistent methodological baseline that can be supplemented with jurisdiction-specific regulatory requirements without fundamentally changing the underlying clinical evaluation approach.
The “chicken-and-egg” problem
One of the most impactful clarifications introduced by ISO/DIS 18969 concerns clinical evaluation planning. The standard requires structured planning of objectives, scope, methodology, and data analysis, while intentionally avoiding the prescription of a rigid document structure.
The standard introduces a dual-track process in which the evaluation of available knowledge and the evaluation of data for the device under evaluation proceed in parallel.
Structured use of available knowledge and integration of non-clinical data
The standard defines “available knowledge” broadly, encompassing all relevant clinical and non-clinical information related to the medical condition, intended purpose, and available alternatives. This includes State-of-the-Art evaluation, medical background, alternative treatment options, applicable standards, consensus guidelines, and known risks and benefits of comparable technologies.
Evaluation criteria as the scientific backbone of the process
A defining feature of ISO/DIS 18969 is its strong emphasis on predefined evaluation criteria. These represent measurable and justified thresholds for acceptable safety, performance, and expected clinical benefits. The standard requires that evaluation criteria be derived from the evaluation of available knowledge and deliberately avoids prescribing fixed evidence thresholds.
This approach supports scientific flexibility while maintaining regulatory robustness and aligns well with existing regulatory concepts.
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Lifecycle thinking and alignment with ISO 14155 and post-market evidence
A strong lifecycle perspective it is adopted, recognizing that clinical evaluation begins early in development when clinical data may be limited and evolves continuously as additional evidence becomes available.
Closely aligned with ISO 14155, the new standard, creates a closed evidence loop in which early clinical evaluation informs the design of clinical investigations, and investigation results are systematically fed back into the clinical evaluation.
Post-market clinical data are recognized as a key input, although the standard intentionally does not impose regulatory obligations such as mandatory PMCF, leaving such requirements to applicable legislation. This lifecycle-oriented approach reflects current regulatory expectations and supports continuous benefit–risk assessment throughout the device’s time on the market.
Closing conceptual and practical gaps in existing guidance
ISO/DIS 18969 establishes a complete international standard describing the clinical evaluation process from planning through to lifecycle maintenance. Unlike regional regulations or guidance documents, the standard is not limited to a specific legal framework and is therefore applicable across global markets. It defines a structured and reproducible methodology covering planning, identification, appraisal, analysis of data , overall assessment, benefit–risk evaluation, reporting, and continuous updating.
For manufacturers operating internationally, this provides a consistent methodological baseline that can be supplemented with jurisdiction-specific regulatory requirements without fundamentally changing the underlying clinical evaluation approach.
Get a clear, practical introduction to ISO/DIS 18969 and learn how to strengthen your clinical evaluation process.
Closing gaps
Overall, ISO/DIS 18969 introduces a more structured and globally consistent approach to clinical evaluation, helping to align regulatory expectations and reduce variability in interpretation. Beyond establishing core principles, the standard emphasizes the integration of clinical evaluation throughout the entire product lifecycle. It promotes early planning, systematic data management, and continuous updates based on emerging evidence.
In addition, it reinforces the importance of methodological quality, decision traceability, and scientific justification, requiring a higher level of rigor in both the generation and assessment of clinical data.
Categories: Clinical Evaluation
Tags: Clinical Evaluation, ISO18969, mdr, Medical Devices
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