The International Medical Device Regulators Forum (IMDRF) held the fifteenth meeting of the Management Committee (MC) in Moscow, Russia on March 18th -21st, 2019. The MC consisted of regulatory leaders from around the world such as: Australia, Brazil, Canada, China, the European Union (EU), Japan, Russia, Singapore, South Korea, and the USA.
In addition, the World Health Organization (WHO) participated as Official Observers while the Asian Harmonization Working Party (AHWP), Pan American Health Organization (PAHO) and Asia- Pacific Economic Cooperation Life Sciences Innovation Forum Regulatory Harmonization Steering Committee (APEC LSIF RHSC) participated as Regional Harmonization Initiatives.
During the 4- day meeting there were over 300 regulatory participants, comprising of Industry experts, representatives, and regulators, discussing items such as: Standards development, improvements, guidance, regulatory updates from the different countries being represented at the meeting, and a Questions & Answers session.
It is also important to note that the IMDRF currently has eight working groups, which are:
1. Regulated Product Submission (RPS) - Canada
2. Medical Device Adverse Event Terminology - Japan
3. Good Regulatory Review Practices - USA
4. Standards - USA
5. Personalized Medical Devices - Australia
6. Unique Device Identification - EU
7. Medical device clinical evaluation - China
8. Medical device Cybersecurity – Canada/USA
These groups play an essential role in the decisions made by the IMDRF Management Committee. The MC approved several proposed documents pertaining to clinical trials and personalized medical devices, allotting a two-month period for these documents for public consultation. They also approved revised documents pertaining to the Final N9 and Final N13 documents which involve non-in vitro and in vitro diagnostic medical device market authorization from the RPS working group. In addition to these documents they approved a host of other documents pertaining to:
1. Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Annex E-F)
2. Principles of Labeling for Medical Devices and IVD Medical Devices
3. Unique Device Identification System (UDI system) Application Guide
4. Use of UDI Data Elements Across IMDRF Jurisdictions
5. Review and Update of the GHTF Principles of In-Vitro Diagnostic (IVD) Medical Devices Classification (GHTF/SG1/N45:2008), and
6. IMDRF Standard Developing Organizations (SDO) Liaison Program
With the approval of these documents the IMDRF also proposed changes to the SOP which includes the New Work Item Proposal (NWIP) adoption processes. Meaning the IMDRF membership criteria will be updated providing additional clarity to entities who seek to become an Official Observer or a Management Committee Member of the IMDRF. At the next meeting (IMDRF-16) a new document indicating the implementation of IMDRF documents by member jurisdictions will be discussed in further detail. Lastly, South Korea has volunteered to serve as the Chair of the IMDRF for 2021.