For nearly 13 years, countries have collaborated on medical device guidance to develop a common set of standards for regulators around the world. The work has been part of the International Medical Device Regulators Forum (IMDRF), which will meet next week in Washington, D.C.
Members include the European Union, Japan, Canada, Australia and the U.S., and the World Health Organization is an official observer. The group has developed guidance documents and discussed topics ranging from early questions such as what is a medical device to how countries can regulate new technologies like artificial intelligence.
Melissa Torres, the Center for Devices and Radiological Health’s associate director of international affairs, spoke to MedTech Dive about the IMDRF’s push to get more countries involved in the group, helping countries with newer device regulatory systems develop, and the challenges around overseeing fast-moving technologies like AI and software as a medical device.
This interview has been edited for length and clarity.
MEDTECH DIVE: What is a top priority or topic that IMDRF will focus on either at the meeting next week or throughout 2024?
MELISSA TORRES: As soon as the FDA took over chairmanship in 2024, one of the big areas that we wanted to prioritize was increasing engagement within IMDRF. Last year, we created a new membership category called the “affiliate membership category.” Not-so-well-developed regulatory authorities — for example, a regulator that’s thinking about developing a medical device regulatory system — can apply to IMDRF and be part of the group. They can engage and understand what IMDRF is doing. Because many of these countries are thinking, “How do we implement some of these documents in our jurisdiction?” IMDRF has documents as simple as the classification of a medical device or the definition of a specific medical device. All of that is encompassed within a lot of the IMDRF documents.
We wanted to think about a mechanism for these countries to be able to engage and understand what’s going on within the group. This new membership category gives them an opportunity to do so. Before this category, it was really difficult to become a member. You had to have a fully developed regulatory system, you had to be able to do pre-market and post-market reviews. It didn’t offer the opportunity for these countries to engage. We’re trying to continue what the European Union [IMDRF’s 2023 chair] had started and increase engagement and membership.
It’s important for these countries to not reinvent the wheel. They may have three people at their regulatory authority, and they think they could do it all. We tell them to think about ways they can rely on these other regulators that are doing premarket reviews, for example, and how can they rely on our decisions already and take that at face value.
What is IMDRF’s AI working group focused on, and what is IMDRF looking at regarding the proliferation of AI in healthcare?
We’ve recently done some multilateral work with the U.K. and Health Canada on good machine learning practices (GMLPs). We issued our first document on GMLPs, and we’ve done predetermined change control plans as well.
IMDRF is building upon that work. The first step was looking at GMLPs. We’ve taken that work — those basic principles we identified — and brought that work into IMDRF to create a more detailed document with the organization. That’s what the AI working group is currently working on.
In January, FDA Commissioner Robert Califf spoke about the challenges around AI, such as the complexity of oversight and the lack of manpower as the use of the technology skyrockets. Do other countries have similar challenges?
It’s all of it, right? I think we’re all struggling on how to fit it into the regulatory framework. It’s so fast evolving. We’ve heard that same challenge from other regulators that are at the table. Even countries that are just developing these regulatory systems ask, “How are you doing this? How are you handling AI?” They don’t even know how to classify medical devices yet, and they’re struggling with what to do about AI. It’s certainly a challenging topic.
I was just in Korea. We had a joint workshop we did between the FDA and Korea’s Ministry of Food and Drug Safety, the country’s medical device regulator, and it was all focused on AI and medical product development. The workshop not only focused on devices, but it also talked about drugs and biologics — we kind of covered the gamut. But it was the same messaging we heard across the board from many regulators: the challenge of manpower, and how to fit AI into regulatory systems that have existed for X number of years and are not really accounting for the fast-changing and evolving technologies right now that we’re dealing with.
Is IMDRF interacting with groups like Advamed or Medtech Europe as it looks at AI, for example, to hear how companies are thinking about using the technology and developing it into devices?
Some of the working groups are only open to regulators, and then other groups are for regulators and industry. AI is actually one of the groups where we have key stakeholders plus the regulators involved because of the vast nature of that topic. We need to have their feedback in the process as well.
What are the biggest challenges IMDRF faces going forward?
I think it is in these areas, AI and software as a medical device. Some of the same challenges we were just talking about. How do you create harmonized documents internationally in these topic areas that are so fast evolving? Because while we’re creating concepts that are sort of at a higher level, they still become outdated so quickly. How do we keep up on this? And how do we think about it continuously? It is a challenge — everybody’s facing that same challenge — but it does give a great opportunity for us to be able to discuss it with all the right stakeholders at the table. I do see these as being the two areas that are going to be the most challenging as we move forward.