The International Medical Device Regulators Forum (IMDRF) has released a new strategic plan outlining its priorities for the 2026–2030 period, placing strong emphasis on expanded stakeholder engagement and internal governance reform. The plan reflects IMDRF’s rapid growth and its evolving role in promoting global regulatory convergence for medical devices.
As international regulatory alignment becomes increasingly important for manufacturers operating across multiple markets, IMDRF’s updated strategy provides insight into how global expectations may continue to evolve in the coming years.
Managing Growth and Long-Term Sustainability
IMDRF noted that its membership has grown substantially in recent years, expanding from 17 members to 47 in just four years. With continued growth anticipated, the organization identified leadership development and long-term sustainability as key priorities.
To support this expansion, IMDRF plans to modernize its governance structure. A governance subcommittee has been tasked with developing a revised governance framework and updating standard operating procedures to better define committee roles, executive responsibilities, and decision-making processes. These changes are intended to ensure that IMDRF can continue to operate efficiently while supporting a larger and more diverse membership base.
Reinforcing Foundational Regulatory Principles
Another major focus of the strategic plan is reinforcing IMDRF’s foundational regulatory principles. Many of these principles originated under IMDRF’s predecessor, the Global Harmonization Task Force (GHTF), and continue to influence international device regulation today.
IMDRF plans to review GHTF documents that remain foundational to global regulatory practice and convert them into updated IMDRF guidance where appropriate. This effort is intended to strengthen consistency across regulatory systems while ensuring guidance remains relevant to modern technologies and regulatory challenges.
Expanding Engagement With Industry and Stakeholders
A consistent theme throughout the strategic plan is IMDRF’s commitment to deeper stakeholder engagement, particularly with the medical technology industry. IMDRF emphasized that collaboration with stakeholders is critical to achieving the right balance between regulatory oversight and timely patient access to innovative medical devices.
The organization plans to continue engaging industry through the IMDRF Industry Group, joint workshops, and bilateral meetings. In addition, IMDRF intends to broaden outreach by identifying new stakeholder groups, expanding opportunities for participation through New Work Item Proposals, and exploring new mechanisms for engagement on shared regulatory priorities.
IMDRF highlighted the importance of transparent, risk-based regulatory processes, noting that unnecessary delays in access can have significant consequences for patients, particularly those with serious or life-threatening conditions.
What This Means for Medical Device Manufacturers
IMDRF’s strategic direction reinforces the growing importance of global regulatory alignment, early stakeholder engagement, and proactive participation in international regulatory initiatives. Manufacturers should expect continued efforts toward convergence and should monitor IMDRF activities closely as new guidance and working groups emerge.
How EMMA International Supports Global Device Strategy
At EMMA International, we support medical device and IVD manufacturers navigating global regulatory convergence and evolving international expectations. Our teams help clients align regulatory strategies with IMDRF principles, strengthen governance and compliance frameworks, and engage proactively with global regulatory initiatives across FDA, EU, and other markets.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
International Medical Device Regulators Forum. IMDRF Strategic Plan 2026–2030. December 2025.
Regulatory Affairs Professionals Society. IMDRF emphasizes engagement, governance reform in new strategic plan. January 6, 2026.
International Medical Device Regulators Forum. Overview of IMDRF governance and stakeholder engagement activities.
