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

Great news again on the clinical evaluation world: ISO 18969 - Clinical evaluation of medical devices - Principles and process for planning and performing clinical evaluation has reached the Final Draft International Standard (FDIS) stage!

In my previous blog "Biological and clinical evaluation of medical devices", written back in December 2022, I shared that ISO/TC 194 had just approved the proposal of this new standard, and that the final document was expected to be published not before late 2025. I also invited you to join me on the journey to understand the process of developing a new ISO standard. Almost four years later, we are getting close to the end of that journey. If you are curious to know where we are, how long it took to get here, and what to expect from the final document, please keep reading!

Where is ISO 18969 on the journey?

If you remember the stages explained in my previous blog, at that time the proposal stage (10) had just been completed and the project had moved to the preparatory stage (20), when the working group of experts (in this case, working group 4 or WG 4) prepares the Working Draft (WD). After successive drafts, the Draft International Standard (DIS) was made available to all ISO members in December 2025 for the enquiry stage (40). In August 2026, the DIS was approved and the project moved to the approval stage (50), which is the current FDIS – as shown in Figure 1.

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, and how many discussions? 

From the approval of the proposal until FDIS, almost 4 years have passed. It is a bit longer than I estimated on my previous blog, but I am not surprised: a standard that brings together experts from different countries, sectors and regulatory backgrounds needs time to reach consensus. After the DIS ballot closed, in March 2026, around 5 months were needed to consider the comments received and approve the project to move forward.

Behind these dates there is a lot of discussion. Between the proposal and the FDIS, the experts from ISO/TC 194 WG 4 met several times, on site and online, and the DIS received 796 (!) comments from ISO members, each of them considered by the working group. For those who, like me, were in the discussions, it was clear that every word counted! 

The FDIS will be made available soon to all ISO members for a last vote and, from this point on, only editorial corrections are allowed to the final text. In other words, the content that was discussed for so long is now considered practically settled and, if the FDIS is approved, the next step is the publication of the standard.

What can we expect from ISO 18969? 

As the standard is not published yet, I will not go into details, but I can share some ideas that, in my opinion, will make a difference.

A common international framework

First, ISO 18969 was elaborated by experts from several countries, with different backgrounds and regulatory experiences, and it is intended to be international. It will not replace the detailed requirements of each region, which will remain in place, but it will bring common ground. Having a standardized way to plan, perform and document the clinical evaluation process will be quite helpful for manufacturers who need to prepare documentation to support several markets.

Clinical evaluation as a process, not a document 

Second, it is important to be realistic: in my opinion, ISO 18969 will not completely change how clinical evaluations are elaborated today. Its value is in showing, in a standardized way, how to do it right. The most important message is that clinical evaluation is a process, not a document to be written at the end of the project. It starts early, together with the design and development of the device, and goes on throughout its life cycle, including the post-market phase. Along the way, it must be connected to other areas, such as risk management, design and development, clinical investigation and regulatory affairs, because a process cannot live in a silo. It only works when the areas involved talk to each other.

Manufacturer responsibility starts with leadership

Finally, ISO 18969 makes it clear that clinical evaluation is a responsibility of the manufacturer, and that it starts at the top. The organization’s leadership is expected to show its commitment by setting up and maintaining a clinical evaluation process, by making sure that adequate resources are available, and by assigning competent people to do the work. In other words, clinical evaluation is not a task to be left with one person or one team: it is an organizational matter, which needs to be planned, resourced and kept updated as the device moves through its life cycle.

How to get ready for ISO 18969?

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. However, nothing prevents us from getting prepared, and the best time to do it is now, not after the publication. A good start is to take an honest look at how clinical evaluation is organized in your company:

• When does it start in the project?
• Who is involved, besides the clinical and regulatory teams?
• Are adequate resources and competent people in place?
• How well does it talk to risk management and to 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 this review is done, the smoother the transition will be, and 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.  

Concluding remarks on ISO 18969

In my previous blog, I said that the wait would be worth it, because the best team of global experts would have contributed. As a technical expert in ISO/TC 194 and a member of the ABNT/CB-26, I can now say it from the inside: the commitment and the diversity of the experts are what make these documents robust, and all the discussions, long as they were, made the text better.

The final goal remains the same: to ensure that devices are fully assessed regarding their performance and safety before and after being released to the market, so that users and patients receive the best care. We are closer than ever, and hopefully the final standard will be well accepted by regulators around the world, which will allow us to have one clinical story on the product to support its global use!

If you would like to discuss how your clinical evaluation process measures up against these questions, contact us. You can also read about our Clinical Evaluation Services.