Third Quarter of 2024: Global Medical Device Regulatory Harmonization Continues with an Emphasis on UDI

By Megan Gottlieb and Evangeline Loh

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.

Legislative updates for UDI

In the past few months, there have been UDI developments in Brazil, Malaysia, Argentina and Australia. Since the U.S. FDA first established its UDI system to increase transparency and improve patient safety, other regulators have followed.

In Brazil, Resolution RDC 886/2024 was released to amend RDC 591/2021 and extend the implementation deadlines for UDI by one year for all risk classes of medical devices except the lowest-risk class. The first deadline will be July 10, 2025, for Class IV medical devices and IVDs. The regulator, ANVISA, also launched a pilot project to test their UDI database system in September.

The regulator in Malaysia, MDA, announced a UDI pilot survey on July 10 as they investigate the potential to implement a UDI system with mandatory compliance beginning in 2027. INVIMA, the regulator in Colombia, began implementation of Decree 1405/2022 on UDI earlier this year. Devices registered before Feb. 8 are subject to a transition period before the UDI-DI needs to be submitted in the online UDI platform, with the first deadline for Class III medical devices and IVDs on Feb. 8, 2025.

The TGA hosted a consultation on UDI in Australia between July 31 and Aug. 14. The TGA expects to begin implementing UDI before Jan. 1; however, it has not yet shared an indication of the timeline for phase-in mandatory compliance.  

Last, we note that in Mexico, the draft of PROY-NOM-241-SSA1-2024, Good Manufacturing Practices for Medical Devices (July 26) did not include comments about UDI.

Global regulatory initiatives

The long-awaited European amending legislation, Regulation 2024/1860, was released. The modifications impact medical devices and IVD regulations. Perhaps one of the most significant global impacts is the additional transition timeframe for legacy IVDs that meet certain additional conditions (application and agreement with Notified Body and no significant change in design and intended purpose, among others). Switzerland and the U.K., remain committed to recognizing these European legacy transition timelines, and hence, we expect amendments to the legislation there, as well.

Concluding remarks

As we proceed to finish the 2024 calendar year, Emergo by UL will continue to monitor global regulatory developments.

We applaud the regulatory updates and the successes in global harmonization and regulatory reliance!