ISO 18969 Reaches FDIS: What It Means for Clinical Evaluation of Medical Devices

ISO 18969, The standard for planning and performing clinical evaluation of medical devices, has reached the Final Draft International Standard (FDIS) stage. Only editorial corrections are now allowed before a final vote by ISO members and publication. The standard treats clinical evaluation as a lifecycle process led by manufacturer leadership, and it does not replace regional requirements.

This update is based on ISO/DIS 18969. The FDIS has not yet been circulated, and the published standard may differ.

In December 2022, I wrote that ISO/TC 194 "Biological and clinical evaluation of medical devices" approved the proposal for this standard, and publication was expected not before late 2025.  

Where does ISO 18969 stand today?

ISO 18969 is at the approval stage (stage 50) of ISO's development process. The Draft International Standard (DIS) was approved in August 2026, after an enquiry stage that began in December 2025. The FDIS will be circulated soon to all ISO members for a final vote.

If the FDIS is approved, the next step is publication of the standard. The content that was discussed for so long is now practically settled.

How long did ISO 18969 take to develop?

ISO 18969 took almost four years to move from proposal approval to FDIS stage. The Draft International Standard alone received 796 comments from ISO members, and the ISO/TC 194 working group considered every one. After the DIS ballot closed in March 2026, the project took about five months to be approved to move forward.

That is a little longer than I estimated in 2022, but it does not surprise me. A standard that brings together experts from different countries, sectors and regulatory backgrounds needs time to reach consensus. The working group met several times between the proposal and the FDIS, in person and online. For those of us in the discussions, every word counted.

What will ISO 18969 change for clinical evaluation?

ISO 18969 is intended to give manufacturers one standardized way to plan, perform and document clinical evaluation. It treats clinical evaluation as a lifecycle process rather than a report, and it places responsibility on the manufacturer, starting with its leadership. It does not replace the detailed requirements of each region.

The standard is not published yet, so I will not go into detail. Three ideas stand out to me.

Will ISO 18969 replace regional clinical evaluation requirements?

ISO 18969 will not replace the detailed clinical evaluation requirements of each region, which remain in place. It was developed by experts from several countries with different backgrounds and regulatory experience, and it is intended to be international. Its contribution is common ground: one standardized way to plan, perform and document the clinical evaluation process.

That will be quite helpful for manufacturers who prepare documentation for several markets. If regulators around the world accept the final standard, it should allow one clinical story for the product to support its global use.

Is clinical evaluation a process or a document under ISO 18969?

Under ISO 18969, clinical evaluation is a process, not a document written at the end of a project. It starts early, together with the design and development of the device, and continues throughout the life cycle, including the post-market phase. It must connect with risk management, design and development, clinical investigation and regulatory affairs.

In my opinion, ISO 18969 will not completely change how clinical evaluations are prepared today. Its value lies in showing, in a standardized way, how to do it right, including how the clinical evaluation report fits into the wider process. A process cannot live in a silo. It only works when the areas involved talk to each other.

Who is responsible for clinical evaluation under ISO 18969?

Under ISO 18969, clinical evaluation is the responsibility of the manufacturer, and that responsibility starts at the top. Leadership is expected to show its commitment by setting up and maintaining a clinical evaluation process, making sure adequate resources are available, and assigning competent people to do the work.

Clinical evaluation is therefore not a task to leave with one person or one team. It is an organizational matter that needs to be planned, resourced and kept updated as the device moves through its life cycle.

How can manufacturers prepare for ISO 18969 before it is published?

An ISO standard is voluntary, and until ISO 18969 is published and recognized in each region, current regulations and guidance remain the reference for clinical evaluation. Manufacturers can still prepare now by taking an honest look at how clinical evaluation is organized in their company.

These questions are a good starting point for that review:

• When does clinical evaluation start in the project?
• Who is involved, besides the clinical and regulatory teams?
• Are adequate resources and competent people in place?
• How well does clinical evaluation connect with risk management and with design and development?
• Is the evidence planned from the beginning, or collected only when the report is due?

Having followed the discussions in ISO/TC 194 WG 4 from the inside, I believe these are the right starting questions. The earlier the review is done, the smoother the transition will be. Sometimes a fresh look, from someone who has followed the development of the standard, helps to highlight what is hard to see from the inside.

What is the goal of ISO 18969?

The goal of ISO 18969 is that medical devices are fully assessed for performance and safety before and after release to the market, so that users and patients receive the best care. That goal has not changed since the proposal stage in 2022.

In my previous update, I said the wait would be worth it because a team of global experts would contribute. As a technical expert in ISO/TC 194 and a member of ABNT/CB-26, I can now say it from the inside: the commitment and diversity of the experts are what make these documents robust, and the long discussions made the text better. We are closer than ever, and I hope regulators around the world will accept the final standard.

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