IMDRF emphasizes engagement, governance reform in new strategic plan

The International Medical Device Regulators Forum (IMDRF) has outlined its vision for the next five years, which includes further engagement with the medtech industry to ensure promising products reach patients quickly. The group also plans to reform its governance structure as it continues to grow its membership to ensure long-term sustainability.

On 19 December, IMDRF published a strategic plan that it intends to implement between 2026 and 2030. The document outlined five focus areas and eight priority activities that it intends to undertake as it expands.

IMDRF noted that its membership has grown from 17 to 47 in just the past four years and is likely to continue growing. With that in mind the group said it wants to focus on fostering leadership and growth of the organization.

"IMDRF is committed to sustaining its strong global leadership while continuing to meet the needs of and engage with its growing number of members and stakeholders," said IMDRF. "In recent years, IMDRF has led globally in expanding its offerings, now conducting training and bilateral meetings with specific stakeholder types (e.g., the IMDRF Industry Group) in addition to leading publication of technical documents on novel and innovative medical device regulatory topics.

"IMDRF recognizes the challenges that growing membership and expanding activities present," the group added. "Therefore, during the timeframe of this strategic plan, IMDRF will focus on fostering sustainable leadership and growth of IMDRF."

To address the growth, IMDRF stated that it would work to modernize its governance structure by having its governance subcommittee develop and propose a new governance structure that better meets its needs for adoption by the management committee. The subcommittee will also be tasked with revising its standard operating procedures (SOP) to clarify different committee and executive roles.

Another focus for IMDRF will be to reinforce its foundational principles, including those that were established by its predecessor, the Global Harmonization Task Force (GHTF). To achieve this goal, the group plans to convert GHTF documents that are still foundational to its regulatory approach into updated IMDRF documents.

A consistent theme throughout the strategic plan is IMDRF's focus on expanding stakeholder engagement, especially with the medtech industry through the IMDRF Industry Group. The group said it is critical to collaborate with stakeholders to strike the right regulatory balance across regulatory regimes to ensure patients are able to get access to care as quickly as possible.

"Treatment delayed could be treatment denied especially for critically ill patients," said IMDRF. "Therefore, in addition to ensuring the quality, safety and effectiveness of medical devices, regulators should also be facilitators ensuring patients have timely access to essential medical devices.

"Fostering a transparent, well-defined, risk-based regulatory process to demonstrate safety and effectiveness could significantly speed up the total time taken for safe and priority medical device innovations to reach patients," the group added. "IMDRF will continue to work together with all relevant stakeholders to proactively identify useful innovative areas and set up Working Groups (WGs) to develop clear guidance to support prospective regulatory convergence in these areas."

In addition to continuing to engage stakeholders through joint workshops and the IMDRF Industry Group, IMDRF said that it will also identify and engage with new stakeholders who can provide critical perspectives and insights. Furthermore, the group stated that it would also seek new opportunities to engage stakeholders with New Work Item Proposals (NWIP), look for new mechanisms to expand its outreach, and open up opportunities for interested parties to engage with IMDRF on shared interests.

IMDRF strategic plan

IMDRF emphasizes engagement, governance reform in new strategic plan

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