FDA official hopes IMDRF meeting will attract new members

As chair of the International Medical Devices Regulators Forum (IMDRF), the US Food and Drug Administration (FDA) will host regulators from around the world in Washington on 11 March to further the conversation on harmonizing global medical device regulations. A key topic of the week-long meeting will be how to develop guidelines for regulators from developing regulatory regimes, according to Melissa Torres of the IMDRF management committee.

Torres, who is also associate director for international affairs at FDA’s Center for Devices and Radiological Health (CDRH), told Focus that a major goal for IMDRF’s 25^th session is to encourage more regulators from developing nations to join the organization as affiliate members and work with the organization to produce guidelines that they can adopt. She said the organization wants to increase its membership that has led it to develop its affiliate membership category which now includes regulators from South Africa, Taiwan, Cuba, Egypt, Israel, Montenegro, and Chile.

“We were being criticized for many years that IMDRF was for well-developed regulators, and nobody could be let into the ‘club,’” said Torres. “As a mechanism to allow these developing countries to come to the table, we created this new membership category.

“What we’ve been trying to do as management committee members over this last year is try to get these developing regulators to the table and truly understand what their needs are,” she added. “Many of them are just developing medical device regulatory systems and looking to IMDRF documents and ways to implement them in their jurisdictions.”

Torres said several developing regulators have applied to become IMDRF affiliate members, and their applications will be reviewed during the upcoming meeting. She also noted that the meeting will allow developing regulators to engage directly with IMDRF regulators and discuss how their reliance on the organization can be effective, which will be the focus of workshops on the first day of the meeting.

As more developing regulators come to the table, “reliance becomes a more important discussion point,” said Torres. “For many of these countries, as they put together their systems, they really truly focus on reliance as they don’t have enough resources to redo everything.

“Our message is to always look at ways to rely on other well-developed regulators decisions in your jurisdictions,” she added.

Torres said that IMDRF management committee members hope the discussions will lead to reliance documents that affiliate members can use. She also said they hope to develop training documents that affiliate members can use when implementing IMDRF guidelines.

Last year, FDA pulled out of the Global Harmonization Working Party (GHWP) that largely represents Asian regulators. The agency said it made the decision after feeling sidelined on key issues. (RELATED: FDA pulls out of medtech forum over divergent perspectives, Regulatory Focus 28 November 2024)

Torres said FDA initially joined GHWP so that the agency could be a link to IMDRF but became concerned that it was replicating work from IMDRF and leading to conflicting regulations.

“In many cases, we saw IMDRF work being taken up by GHWP but then modifications were being made and then we ended up with two different versions of similar types of documents and really de-harmonization,” she said. “It became very clear to us while [FDA] were members of the program that we were not really making an impactful change and had a lot of growing concerns with the direction things were going in and us taking of chairmanship of IMDRF, so we decided to pull out.”

Despite the concerns with GHWP, Torres said IMDRF is still hoping to work with the group and foster a relationship to harmonize regulations and plans to engage its members at the upcoming meeting. She also noted that several GWHP members have applied for affiliate membership at IMDRF.

As European regulators work to reform their regulatory regime and implement the EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR), Torres said European members of IMDRF have brought up their implementation challenges to the group to get their opinion. She said the issue has led them to become more engaged with IMDRF in the hope of finding more harmonization across regimes and learning from other jurisdictions.

Torrs said the upcoming IMDRF meeting is expected to be the largest yet, with more than 1,000registered attendees.

“We have 400 attendees in person and over 775 people that are attending online,” she said.

For comparison, Torres noted that one of the largest previous IMDRF meetings was held in China with almost 600 attendees, though they didn’t have the option to attend that meeting virtually.

“We haven’t seen these numbers in the past, that in and of itself has shown interest in IMDRF and international harmonization activities,” she said.

The first two days of the IMDRF meeting are open to the public, with the first day consisting of workshops and the second consisting of open stakeholder forums where the members can update the group on their continued harmonization efforts, according to Torres. However, the last three days of the meeting are closed to the public as the management committee invites key stakeholders to provide feedback and then hold meetings to decide on new work item proposals and potentially approve final documents.

Torres said IMDRF has several work item proposals they plan to address during the meeting but declined to comment on specific items. However, she did note the management committee is looking at discussing work item proposals addressing artificial intelligence/ machine learning (AI/ML) and in-vitro diagnostics (IVD).

“Those may be new work items with new documents and potentially new working groups that may be formed under IMDRF,” said Torres.

FDA official hopes IMDRF meeting will attract new members

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