ISO — A new ISO draft standard proposes a common, life-cycle-wide method for showing device safety, performance, and benefit-risk using human clinical data signaling tighter, more consistent expectations for clinical evidence worldwide.
INTRODUCTION
ISO has released ISO/DIS 18969, a Draft International Standard that defines terminology, principles, and a process for the clinical evaluation of medical devices. The draft aims to help manufacturers demonstrate that devices are safe, perform as claimed for their intended use, and have a positive benefit-risk balance—and it clarifies who is responsible for doing what within the evaluation. The text is not targeted at IVDs, though certain parts may still be useful depending on jurisdiction. The draft sits in the DIS ballot stage under ISO/TC 194.
KEY TAKEAWAYS FROM THE ISO/DIS 18969 GUIDANCE
- Purpose: Provide a structured, scientifically sound approach to clinical evaluation across the entire device life cycle.
- Verification goals: Confirm safety, performance/effectiveness, sufficient clinical evidence, and an overall positive benefit-risk in the intended population.
- Claims alignment: Ensure clinical evidence matches the manufacturer’s intended use and claims.
- Process integrity: Emphasize scientific conduct and credible conclusions.
- Roles & responsibilities: Define what the manufacturer and contributors must do within the evaluation.
- Regulatory relevance: The draft notes it can be used for regulatory purposes; regulators and conformity assessment bodies are among the intended users.
- Scope note: Not applicable to IVDs (with potential selective applicability).
- Status: DIS enquiry stage (typical 12-week ballot); 42-page draft entry under ISO/TC 194.
WHAT IT MEANS FOR MANUFACTURERS
- Stronger evidence-to-claim traceability. Expect heightened scrutiny that each label/marketing claim is backed by fit-for-purpose clinical endpoints and data. Start mapping claims to evidence now and flag gaps for remediation.
- Lifecycle maintenance not a one-off. Clinical evaluation must be maintained and refreshed as new data emerge (PMS, PMCF, vigilance, literature). Build review triggers into your procedures.
- Methodology and competence on record. The draft spotlights scientific conduct and clear responsibilities. Ensure your CER authors/appraisers have documented competency and your process includes independent, qualified review.
- Tighter integration with QMS. Link your clinical evaluation to risk management, change control, and post-market surveillance so benefit-risk stays current and demonstrable.
- SOP and template refresh. Update the CEP/CER templates, evidence grading schema, benefit-risk methodology, and a claims-evidence matrix. Plan a concise gap assessment against the draft now; schedule a deeper update once the text advances to FDIS/IS.
CONCLUSION
ISO/DIS 18969 points to a more unified global board for clinical evaluation. While still in the DIS phase, the direction is clear: robust, claim-matched evidence maintained throughout the life cycle, with clear accountability and scientific rigor. Manufacturers that start aligning processes, roles, and templates now will be well-positioned when the standard moves to publication.