We present our insights from the past quarter. Advances in regulatory harmonization, as shared after the first three months and second three months of the year, continue. While it may have been a summer break for many, regulatory developments abound.
This update features regulatory harmonization and a number of global developments revolving around Unique Device Identifiers (UDI).
Word of the day: regulatory reliance advances
The International Medical Device Regulators Forum (IMDRF) hosted its 26th annual meeting before the Regulatory Affairs Professional Society (RAPS) Regulatory Convergence. Day one's theme was “Developing a Medical Device Regulatory System.” Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health (CDRH), FDA, opened by reminding participants that “everyone has a role to play” in global regulatory harmonization.
Reliance was a term used extensively. Regulators lauded the activities of the former Global Harmonization Task Force (GHTF) and the IMDRF as successors to the GHTF for the supportive guidance documents as well as opportunities to engage and learn from each other. It is clear the entire global enterprise is committed to reliance and the benefits afforded to “save resources, encourage innovation, bring devices to the market faster, and ensure patient access” (IMDRF Outcome Statement March 11-15).
Later in the week, at the RAPS session on the update from the U.K. regulator, MHRA, Robert Reid, Ph.D., Deputy Director, shared that the proposed reliance routes (announced in May) to leverage the former GHTF founding member authorizations (less Japan at the moment) in place of UKCA Marking, will be included in the pre-market statutory instrument expected in 2025.
We also continue to see regulators enhance existing regulatory reliance regimes, including in Australia and Israel.
Third Quarter of 2024: Global Medical Device Regulatory Harmonization Continues with an Emphasis on UDI
This update features regulatory harmonization and a number of global developments revolving around Unique Device Identifiers (UDI).
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