New Technical Document to Facilitate Adverse Event Data Exchange

By Amelia Boldrick and Elizabeth Pugh

Background

The International Medical Device Regulators Forum (IMDRF) published a new technical document from the Adverse Event Terminology Working Group (AET WG) this month Common Data Set for Adverse Event Data Exchange Between IMDRF Regulators, or in brief, N85.

N85 builds on the Universal Data Set (UDS) introduced in the seminal Global Harmonized Task Force (GHTF) guidance document Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices (GHTF/SG2/N54R8:2006), or N54. N85 is intended to standardize the industry-submitted adverse event data that IMDRF members can request or share with one another preemptively via a common data set.

Adverse event data sharing

Global regulators may request or share adverse event data when there are suspected regional or global trends in adverse events or suspected safety signals. Select members of the IMDRF Management Committee can share vigilance information through the established by GHTF National Competent Authority Report (NCAR) exchange program.

However, in our experience, it is most commonly used by European (EU) competent authorities to share data made available in one member state with other EU members. Notably N85 does not limit the sharing of data to IMDRF management committee members. It, however, notes that regulators who request data are expected to share findings from their review with the regulator(s) who share data.

The future of signal detection

N85 introduces a new potential purpose for adverse event data sharing between regulators: the development and testing of analytical algorithms.

As is the case with the global healthcare system, regulators are also eager to leverage the power of artificial intelligence and machine learning. These advances in technology can identify patterns and trends in adverse event data that may otherwise be too cumbersome and labor-intensive to monitor and detect manually.

Draft IMDRF guidance open for public consultation

A draft guidance document, Considerations for the Selection of IMDRF Adverse Event Terminology, is currently open for public consultation through December 9. The purpose of this manual is to provide Industry and healthcare professionals guidance on how to correctly and consistently use IMDRF coding. This draft guidance states that each incident report should have at least one code from each group of terms and that these may change with subsequent reports.

The suggestion to include one code from each group of terms is not required in any market currently that we are aware of. In the EU, Switzerland and the U.K., Annex A, E and F codes would be required in an initial report and B, C, and D are required in the final report. In fact, Emergo has received correspondence from BfArM, the German competent authority, that they do not want Annex B, C, and D codes identified on an initial report as the investigation is not complete and this may affect the chosen codes. It will be interesting to see if there will be any changes to the draft prior to publication as a final document based on feedback.

The United Kingdom Medicines and Healthcare Products Regulatory Agency will also hold a webinar on Oct., 24 to provide an overview of the draft IMDRF guidance and underlying principles.

Concluding remarks

The use of accurate and consistent IMDRF adverse event terminology and coding is becoming increasingly important in vigilance reporting, as these form the basis for regulator adverse event trends and signal detection. Additionally, their use in risk files allows for the alignment of manufacturer post-market surveillance activities with those of the IMDRF regulators.

However, the utility of IMDRF adverse event terms and codes may not be limited to post-market activities, and their incorporation in pre-market clinical investigations could possibly decrease the likelihood of unexpected changes to the benefit-risk assessment of a device post-market.

N85 continues the 2024 IMDRF theme of regulatory reliance. Emergo by UL, as always, looks forward to further developments in global regulatory harmonization.