First Quarter of 2024: Global Medical Device Regulatory Harmonization is the Theme

By Evangeline Loh

With the first three months of 2024 complete, global regulatory harmonization appears to be the theme to start the year.

In the interest of categorizing the first quarter, we have Quality Management System (QMS) updates, legislative reforms, mostly for IVDs, and the  International Medical Device Regulator Forum (IMDRF) annual meeting. All of this signals successes for global harmonization. Read on for more of our insights.

QMS updates

There have been gains for the IMDRF Medical Device Single Audit Program (MDSAP).

The U.S. FDA has been a founding member of the MDSAP. And, officially (and finally) heralded its commitment to the Quality Management System Regulation (QMSR, 21 CFR Part 820) Final Rule.  The QMSR Final Rule (posted February 2) becomes effective in two years which further aligns the QMSR with the international standard ISO 13485.

While the legislation in South Korea was posted in 2023 (December 19) MFDS Notice No. 2023-79  Medical Device Manufacturing and Quality Control Standards, the guidance was not released until March (Guidelines to Use MDSAP Audit Results, Guide-1349-01). The regulator in South Korea, the MFDS, has been an affiliate member of MDSAP. Effective December 19, manufacturers can use the results of an MDSAP audit/MDSAP certificate to waive the on-site Korea Good Manufacturing Practice (K-GMP) audit.

In Brazil, Resolution RDC 850/2024 was advanced by the medical device regulator, ANVISA, to extend the validity of Brazil Good Manufacturing Practice (B-GMP) when an MDSAP certificate is presented. This initiative has been swift. The consultation was in October, the RDC in March, and effective the first of April. Hence, B-GMP certificates based on a MDSAP certificate will expire in four years, instead of two.

These QMS updates all demonstrate the benefits of the IMDRF MDSAP.  

Legislative updates, IVDs

There have been significant IVD legislative updates. The last day in January proved to be a momentous day for the two largest medical device market regulators, the U.S. FDA and Europe (EU). The FDA announced its intent to reclassify most Class III IVDs to Class II. This coincides with a proposed rule (September) to regulate laboratory-developed tests (LDTs) as IVDs.

In the EU, the EU Commission shared a draft regulation to amend the In Vitro Diagnostic Devices Regulation (IVDR, 2017/746). The proposed draft would allow legacy IVDs additional time to comply with the IVDR. Analogous to the Medical Devices Regulation (MDR, 2017/745) amending Regulation 2023/607, manufacturers would need to engage a notified body by May 26, and sign an agreement with the notified body by September 26 for the legacy IVD or a substitute IVD. The specific deadlines are two years before the date of compliance.

ANVISA has released three guidance documents to support Resolution RDC 830/2023 on IVDs. Again, RDC 830/2023 was issued in December and would become effective in June. The guidance is intended to support manufacturers in their transition to the revised IVD legislation and includes a Q&A document, IVDs with a change in classification, and IVDs with different classifications.    

IMDRF 25^th annual meeting

The 25^th IMDRF meeting was hosted by the U.S. FDA. The workshop on the first day was titled Reliance. There were sessions on pre-market, post-market and next steps.

"The first session featured presentations from regulatory authorities, industry and the World Health Organization (WHO). The speakers defined what reliance is, described how reliance is used globally, articulated the role of standards in supporting reliance and explained why reliance is important.

In the second session, regulatory authorities and the Pan American Health Organization (PAHO) described specific premarket reliance models and industry representatives highlighted their experiences using these models. During the panel discussion with questions and answers, the speakers emphasized that models of reliance save resources, encourage innovation, bring devices to the market faster, and ensure patient access.

In the third session, speakers from regulatory authorities and industry presented case studies on reliance during post-market surveillance and monitoring.

The final panel featured a moderated discussion with regulators and industry representatives on opportunities to implement reliance more globally. The panelists opined on potential activities for the IMDRF to undertake to support reliance.”

• IMDRF Outcome Statement, March 11-15, 2024

Based on the discussion during the Reliance workshop, regulators and industry recognize the tremendous benefits of global harmonization or “reliance” (or recognition).

Concluding remarks

The regulatory updates in the first quarter represent a triumph for global regulatory harmonization. The IMDRF continues to advance its initiatives. Progress has been noted in all areas, to identify a few: QMS requirements (MDSAP), regulatory submissions and post-marketing surveillance.

We at Emergo by UL are pleased by these regulatory updates, as we champion global regulatory harmonization to improve patient safety. We will continue to monitor and share global regulatory news.