Updates from IMDRF: What’s next for the working groups

At the International Medical Device Regulators Forum (IMDRF) annual meeting in Washington, DC, regulators presented updates on the work underway within all seven IMDRF working groups. Here, AgencyIQ provides highlights from these updates, including current and future project plans.

BY LAURA DIANGELO, MPH | MAR 20, 2024 4:13 PM CDT

IMDRF and its working groups

The International Medical Device Regulators Forum (IMDRF): IMDRF is an international coalition of regulators that arose as a regulators-only group after the dissolution of the Global Harmonization Task Force (GHTF) in 2011. The group began with regulators from Australia, Brazil, Canada, China, the E.U., Japan, the U.S. and the World Health Organization (WHO). In 2024, the core group has grown to also include regulators from Singapore, South Korea, and the U.K. (rejoined); the WHO is now an official observer. Other official observers include Argentina (National Administration of Medicines, Food and Medical Technology – ANMAT) and Switzerland. IMDRF Affiliate Members in 2024 include the device regulatory authorities in Chile, Chinese Taipei, Cuba, Egypt, Israel, Montenegro and South Africa. IMDRF also includes several regional harmonization initiatives, including the Asia Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum’s (LSIF) Regulatory Harmonization Steering Committee, the Global Harmonization Working Party (GHWP), the Pan American Health Organization (PAHO), and the African Medical Devices Forum (AMDF). For 2024, the U.S. FDA is the Chair and Secretariat of IMDRF.
The IMDRF’s work involves collaborating on key regulatory topics in support of international harmonization. IMDRF currently hosts seven working groups (WGs) on priority areas in medical device regulation: 1) adverse event terminologies, 2) artificial intelligence (AI)/machine learning (ML)-enabled devices, 3) good regulatory review practices, 4) personalized medicine devices (PMDs), 5) quality management systems, 6) regulated product submissions, and 7) software as a medical device (SaMD). The WGs, which are comprised of representatives from the different regulators engaged with IMDRF, work to align on approaches in their priority areas and will, as applicable, issue technical documents (i.e., guidance) on best practices in these subjects.
In early March 2024, IMDRF hosted its annual session in Washington, DC, with several days of presentations from IMDRF members, affiliates and initiatives, as well as responses from regulated industry. Here, AgencyIQ offers working group-related highlights from this annual meeting.

First, updates from five of the IMDRF’s WGs

At the event, regulators provided updates on several WG efforts: STEPHANIE SHEDD from the FDA’s Center for Devices and Radiological Health (CDRH) international affairs team provided information about the current workflows for five of the IMDRF’s WGs. While she stressed that these updates “are definitely not representative of all the work that’s happening in the background,” she provided an overview of their current projects.
First up, the Adverse Event Terminology WG is working to “improve, harmonize and, where necessary, expand terminology used to code information related to adverse events and also to establish and maintain IMDRF adverse event terminology,” she said. Notably, IMDRF’s technical document on terminology for categorizing adverse events was finalized in 2020, but the Annex was updated earlier in March 2024, “and the work is continuing on a common data set for adverse event reporting and exchange between regulators,” according to Shedd. This WG has operated “some pilot exchanges to identify areas that need further clarification or modification,” she explained, and a “third pilot is underway that will share larger datasets and expand the pilot to ensure that everything can be sent accepted and used in a useful dataset.” The WG is working on a new document that will offer “points to consider for code selection” as well as “additional guidance on how to use the coding sets in conjunction with maybe another coding system to fully capture the adverse event, and additional options for sharing this information in the future.” Finally, she noted that this WG has reinstated in-person meetings and is currently meeting every three weeks.
Next, the Good Regulatory Review Practices WG “aim[s] to develop documents that harmonize global marketing review requirements,” said Shedd. She pointed to the work that Health Canada and the U.S. FDA are doing with the electronic submission template and resource (eSTAR) pilot program, noting that “that’s their responsibility and their hard work.” As an update, Shedd noted that “they’ve been making minor revisions to improve clarity, consistency, and clarify the scope and the interrelationships between the documents that they are responsible for, and they will be expected to be available later this year, so please stay tuned for those.” As AgencyIQ has previously discussed, the eSTAR pilot was intended to assess the feasibility of submitting certain device applications to both U.S. FDA and Health Canada, and experience from that effort has demonstrated that there are adjustments to be made to the process.
The AI/ML-enabled device WG is currently drafting a document on guiding principles for good machine learning practices (GMLP), according to Shedd. This is based on the work of the U.K.’s MHRA, FDA and Health Canada in 2021, but also “include[es] updates reflecting recent advancements in AI” – in particular, “the needs of generative AI and large language models, and ensuring alignment with and referencing other IMDRF documents.” According to Shedd, the WG intends to get those documents “out for public consultation by later this year.” Going forward, “a deeper dive into GMLP” remains of interest for the group, as do pre-determined change control plans (PCCPs). Notably, PCCP “has been proposed as a new work item to the Management Committee,” and the group of regulators that put forth the GMLP principles (Canada, US, UK) also put out a document on “guiding principles” for PCCPs in 2023.
The Personalized Medical Devices (PMD) WG is tasked with “develop[ing] technical guidance and harmonized recommendations for regulating personalized medical devices across various jurisdictions and to engage with stakeholders.” This group put out a new guidance on PMDs in late 2023, focusing on the implications of point-of-care manufacturing. According to Shedd, “this group is also proposing a plan to develop training materials for personalized medical device stakeholders,” and “there will be new definitions and concepts for the regulation of PMDs and point-of-care manufacturing for medical devices.”
The Quality Management Systems (QMS) WG “is continuing to work on updating the supplier controls GHTF documents,” and are meetings every two weeks. Per that working group, the GHTF document on supplier controls (as well as their other documents related to risk management, process validation, and corrective and preventive action) “were developed between 2004-2010 and contain outdated QMS and risk management principles.” Now, the group is working to better align the concepts with the current versions of the device quality system standard (ISO 13485) and risk management standard (ISO 14971). Currently, the WG is engaging with the ISO working groups, industry and notified bodies, and “are planning to submit a draft document to the management committee this year.”

Next, updates from the SaMD Working Group

MIRA JACOBS of CDRH’s Digital Health Center of Excellence (DHCoE), presented on behalf of the SaMD WG.
Up first: N81 (Medical Device Software: Considerations for Device and Risk Characterization). “Just to kind of give it away now, the big update is that we do have a new document out in draft, and we would love to get your comments on it while that comment period is open,” said Jacobs, referring to the new draft technical document that was issued in February 2024. As AgencyIQ discussed at the time, that document takes a broader view of risk categorization for software-enabled medical devices than IMDRF’s longstanding SaMD risk categorization document (N12), which was finalized in 2014. Jacobs explained that the new document “really aims to add on to existing concepts that N12 put forward now 10 years ago,” further noting that “it’s also fair to say that the last 10 years have probably really tested these documents.”
While N81 isn’t intended to replace N12, they are working on an update there as well. For now, Jacobs confirmed that the new draft N81 is “not intended to replace the current risk categorizations framework” (N12). That said, “we will be looking into developing a new risk framework,” said Jacobs, “that intends to build upon the concepts that we’ve now introduced in N81, rooted in all the learnings from N12, and that will hopefully allow us to kind of keep pace with the absolutely rapid movement of this.”

Finally, updates from the Regulated Product Submission (RPS) working group

Health Canada’s DANIEL YOON presented on behalf of the RPS WG.
The RPS WG is focused on defining content and structure of regulatory submissions: “The RPS working group developed the Table of Contents to provide a harmonized format for regulatory submissions, versions for non-IVDs [N9] and IVDs [N13] were created, and this was done by using a folder structure where each folder corresponded to a specific submission topic or a sub-chapter,” explained Yoon, citing the Table of Contents technical guide from 2019.
Based on that experience, however, “the working group recognized that there were technical limitations inherent in the structure that prevented broad uptake” of the technical guide and table of contents (ToC) structures, in particular the “character in sub-folder limits and manual construction.” The WG was extended “to update the ToC” and “explore the use of a new dynamic submission template to build regulatory submissions.”
The WG opened consultations on proposed new documents for both N9 (non-IVDs) and N13 (IVDs) in 2023, which represented “extensive updates,” said Yoon. “In addition to adding the requirements of two new regulators from Korea and the U.K., there were also structural changes and improvements to address obsolete information and incorporate new or updated content and regulatory references,” he explained. From those consultations, “we’ve received over 200 comments from 10 stakeholders,” and the WG “accepted approximately 60% of all comments, including ones that were partially accepted, and we’ve made many, many small changes to clarify recommendations as well.”
The revised N9 and N13 went before the IMDRF Management Committee at the forum, and “if the documents are approved, the working group will turn its attention to the dynamic template,” according to Yoon. “This will include leveraging the updated ToC requirements, determining a governance structure, and developing a mechanism for keeping requirements current.”
What are the goals for a dynamic template? Per Yoon, they’re extensive, and intended to help applicants verify that their applications include necessary information “in a standardized, accessible format and ultimately help enable regional participants to quickly process submissions,” he said. He pointed to eSTAR as “an example of a dynamic template that could be used.”
Speaking of eSTAR: As noted above, there is currently an ongoing pilot in which the FDA and Health Canada are assessing the feasibility of joint submissions via eSTAR, but “Health Canada is also conducting its own regional pilot as well,” said Yoon. Going forward, the eSTAR experience “will help inform the RPS group as we work through to develop a dynamic template,” he said. However, he did not describe what, exactly, such a tool from IMDRF would look like.

Analysis and what’s next

Overall, it’s a busy time for the IMDRF WGs. The representatives at IMDRF’s forum touted a bevy of documents that industry may expect to see in the coming year, including new documents on AI/ML and, potentially, new documents on supplier controls from the QMS WG. Other documents that do not have a concrete timeline but do appear to be in the works include a new risk categorization document for software-enabled products, the new versions of N9 and N13 based on the consultation feedback, and potential updates to adverse event terminology coding and code selection.
Further, it appears that they’re working to broaden their scopes, with many of the updates from WG indicating that they’re putting forth new documents and new topic areas before the IMDRF management committee. In effect, the IMDRF WGs are looking to expand the types of topics in which they work, including high-priority areas like PCCPs. Ensuring WG alignment on these key priorities may help set the stage for a precedent for international harmonization on still-emerging policy areas, even as IMDRF works to keep up with the pace of policymaking from individual regulators and industry innovation.
What’s next? The IMDRF annual session covered various other topics as well. Stay tuned for another AgencyIQ article that will provide an overview of the top themes that emerged from this multi-day meeting.

Featuring previous research by Corey Jaseph.

To contact the author of this item, please email Laura DiAngelo ( [email protected]).
To contact the editor of this item, please email Chelsey McIntyre ( [email protected]).

Key Documents and Dates

25th Management Committee Meeting of the IMDRF, March 11-15, 2024