ISO 18969 临床评价标准即将发布

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A New ISO 18969 – “Clinical Evaluation of Medical Devices” Is on the Way: Understanding the Development of a New ISO Standard

Great news on the clinical evaluation world: ISO/TC 194 “Biological and clinical evaluation of medical devices” has approved the proposal of the new standard ISO 18969 – Clinical evaluation of medical devices!

The first draft was already reviewed and continued work on the new standard will start immediately, but the final document is expected to be published not before late 2025. If you are curious to know why it will take so long, please join me in this journey to understand the process of developing a new ISO standard!

1.      The International Organization for Standardization

The International Organization for Standardization (ISO) is an independent, non-governmental international organization which was founded in 1946 and began operating in 1947. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market-relevant standards that provide solutions to global challenges  in a variety of fields. An International Standard (IS) is a document containing practical information and best practice. In the medical device industry, its main goal is to protect society as it provides agreed procedures for developing  devices that are safe and perform as intended. It also benefits industry and regulatory authorities, as one side knows what to expect from the other. A new ISO standard is only developed if its need is identified by a team of experts, who come from a variety of interested parties: industry, government, consumer organizations, academia, and nongovernmental organizations. The ISO Central Secretariat – ISO/CS – is the responsible for coordinating the development process and publishing the final standards [1, 2].

2.      Development of ISO Standards

The development of International Standards and other ISO deliverables is carried out by ISO technical committees (TCs) and their subcommittees or working groups (WGs), or by project committees. Only experts that  are nominated by the members that have agreed to actively participate in the project concerned are allowed to be part of the WGs.

The stages of development for ISO deliverables are summarized in Figure 1 and following detailed.

Figure 1: Stages for developing ISO deliverables [1].

The first step is intended to confirm the need of a new IS in the subject area and it is called the proposal stage (10). At this point, a New Work Item Proposal (NP) is submitted to the committee for vote. This stage has just been completed for NP/ISO 18969 – Clinical evaluation of medical devices, which is now in the preparatory stage (20), when a working group of experts is set up by the parent committee, which in this case is the ISO/TC 194, to prepare the Working Draft (WD). Successive WDs can be elaborated, until the experts are sure that the best solution has been proposed. The draft is then forwarded to the working group’s parent committee that will decide the next step,  which can be either committee or enquiry stage. The committee stage (30) is  not mandatory, and if applicable, the Committee Draft (CD) is provided to the members of the committee for commenting and/or voting. Successive CDs can be available until there is consensus in that particular technical content. During the enquiry stage (40), which is mandatory, the Draft International Standard (DIS) is submitted to the ISO Central Secretariat (ISO/CS). It is then made available to all ISO members for 12 weeks for additional comment and vote. The DIS is approved if 2/3 of the members of the committee accepts its content and not more than 1/4 of the total number of votes cast disagrees with it. If the DIS is approved, the project is finally ready for publication. If the DIS is rejected or approved with significant comments or technical changes in the previous stage, an additional step must be carried on: the approval stage (50), in which the Final Draft International Standard (FDIS) is submitted to the ISO Central Secretariat (ISO/CS). The FDIS is then available to all ISO members for 2 months  for additional voting to decide whether the standard is or not suitable for publication. After the FDIS, only editorial corrections are allowed to be made to the final text. Lastly, at the publication stage (60), the final document is published [1]*.

3.      What happens after publication?

After being published, an international standard (IS) must remain updated in order to keep its relevancy. Therefore, ISO applies the “systematic review (SR)” process, which ensures that standards remain up to date. Comments obtained at  the SR stage can therefore lead to a revised standard, determining whether it should be confirmed, revised/amended, converted to another form of deliverable, or withdrawn (WDRL) [3]. The full life cycle of an ISO standard is presented in Figure 2.

Figure 2: Life cycle of a ISO standard [4].

4.      Concluding remarks

Currently, it is hard on manufacturers try to please different regulatory authorities for which the bar for clinical evaluation is set on so different levels. Even the International Medical Device Regulators Forum (IMDRF), formed by Australia, Brazil, Canada, China, EU, Japan, Russia, Singapore, South Korea, UK and USA, made good progress in providing manufacturers with guidance on how to conduct and document a clinical evaluation, a specific international standard will be an important milestone for the medical device industry, as ISO is made of 165 (data from 2020) different national standards bodies which all will be invited for elaborating the new ISO 18969.

As a recent member in the ABNT/CB-26, Brazilian mirror of the ISO/TC 194, the technical group responsible for the standardization of biological and clinical evaluation/investigation of medical devices (ISO 10993 series, ISO 14155, ISO 18969), I have witnessed the commitment of all the experts in providing their knowledge to reach the best practices. Further than aiming to put manufacturers and regulators on the same page, the final goal is to ensure that devices will be fully assessed regarding their performance and safety before being released to the market, and therefore the user/patient will receive the best care.

There is still a long way until ISO 18969 is finally published. However, the wait will definitely be worth, because we have the guarantee that the best team of global experts will have contributed. Hence, the final standard will be well balanced, and hopefully well accepted by regulators around the world, which will allow us to have one clinical story on the product to support its global use!

Patrícia da Silva Peres

References

• ISO, My ISO job – What delegates and xperts need to know. 2020.
• ISO, ISO in brief – Great thing happen when the world agrees. 2019.
• ISO, Guidance on the Systematic Review in ISO. 2019.
• ISO. Ballot types and stages. 2022; Available from: [color=var(--fs-experimental-link-color)]https://helpdesk-docs.iso.org/article/228-ballot-types-and-stages.