26th session of the International Medical Device Regulators Forum (IMDRF)

I’ve been in the industry for many years and have heard countless times about global harmonization and regulatory convergence. However, it never felt as real as when I attended the 26^th session of the IMDRF last week, on September 16-17, 2024.

Was it the fact that the size of the IMDRF community quadrupled since 2011? (From 8 founding members in 2011 to 32 organizations now, including several recently added from Africa). About IMDRF | International Medical Device Regulators Forum

Or maybe it was hearing the stories of several countries who adopted the WHO Global Model Regulatory Framework and IMDRF technical documents to build their regulatory systems. WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices 

Or maybe it was hearing about the increased acceptance and use of the Medical Device Single Audit Program (MDSAP) around the world.

The topic of regulatory reliance based on trust came up several times over the two days. To me, this is the ultimate result of regulatory convergence. What an exciting time for manufacturers and regulators who all want to better utilize their resources!

I only wish for the same common-sense principles and efforts for efficient use of resources applied for Conformity Assessment Bodies (CABs) as well. While we see more regulatory convergence and reliance, we are experiencing a proliferation of new recognition schemes for CABs and requirements for local ISO 13485 accreditation. Why not rely on the work of IAF accreditors?  About - IAF

More helpful links:
Medical Devices Auditing and Certification Services (intertek.com)

MDSAP | Medical Device Single Audit Program (intertek.com)