IMDRF Updates Guidance on Global Regulatory Submissions

By Evangeline Loh on behalf of, and with the Global Consulting Team

Global harmonization continues to excite us all. And, global harmonization of medical device registration submissions is one way to advance the objectives of the International Medical Device Regulators Forum (IMDRF) and regulatory reliance. These documents are a must-read for any serious regulatory professional.

Here we elaborate on our regulatory update featured in April 2023.  

Background on IMDRF RPS WG

The IMDRF is a formidable collaboration of medical device regulatory agencies, including Brazil, China, the European Union (EU), Japan, South Korea, the United States (US) and the World Health Organization (WHO).

We explained the extensive history of the IMDRF Regulated Product Submission (RPS) working group (WG) in April 2023. As the charter of the RPS WG is laudable, we share it again: “to build on the common Table of Contents (ToC) for medical device regulatory submissions and create a dynamic template that supports the electronic transmission of regulatory submissions.” As we continue to report, the IMDRF RPS WG continues to make progress.

Background on IMDRF RPS ToC

In April 2023, revision four (R4) of the ToC guidance for both medical devices (“non-in vitro Diagnostic Device Market Authorization ToC” nIVD MA ToC, IMDRF/RPS WG/N9) and in vitro diagnostic (IVD) devices (IVD MA ToC, IMDRF/RPS WG/N13) was under consultation. First piloted in 2015, the guidance had been revised three times: R1 (27 May 2014), R2 (27 March 2018), and R3 (21 March 2019).

The IMDRF RPS WG has now published (June 25) Edition 4 of the nIVD MA ToC (IMDRF/RPS WG/N9Final:2024 (Edition 4)) and IVD MA ToC (IMDRF/RPS WG/N13Final:2024 (Edition 4)) after approval by the IMDRF Steering Committee.

Edition 4 of the IMDRF ToC

The document revision history table explains that R4 represents “significant revisions”.  Edition 4 of the nIVD MA ToC expands from 53 pages to 164 pages: Edition 4 of the IVD version reports similar increases.  The intent here isn’t to provide a gap assessment between Edition 3 and 4, perhaps that is for another update, however, the Other General Notes section introduces updates on the current state of affairs with the U.S. Food and Drug Administration (FDA) and EU.

For the US FDA, readers are reminded of the guidance related to the electronic Submission Template And Resource (eSTAR) and eCopy. In the EU, there is a discussion about the technical document requirements per the regulations, including references to the Medical Device Coordination Group (MDCG), harmonized standards (Annex Z) and General Safety Performance Requirements (GSPR).

The tables in the chapters provide extensive guidance in the column, Regional Content.  

Why review Edition 4 of the IMDRF ToC?

If one claims there is insufficient guidance on developing regulatory submissions, we suggest a review of these guidance documents. These are a veritable treasure of information. Reviewed by the enterprise and finalized by regulators, this is helpful guidance. In addition, the revisions to the legislation for medical devices and IVDs in Brazil (RDC 751/2022 and RDC 830/2023, respectively), Annex II both refer to the Edition 3 IMDRF guidance for the regulatory submissions.