IMDRF Releases New and Revised Documents Following March Meeting
Posted 02 July 2019 | By
The International Medical Device Regulators Forum (IMDRF) posted four new final documents on unique device identification (UDI) and labeling principles, and four revised documents on IMDRF’s standard operating procedures (SOPs), the Table of Contents (ToC) format and adverse events.
Of the four new documents, three are on UDI. These include one technical document—the UDI system application guide—and two information documents on the system requirements
relating to UDI use in health care and the use of UDI data elements
across IMDRF jurisdictions.
The 68-page UDI application guide
operationalizes a 2013 UDI guidance
in which IMDRF set forth a high-level conceptual framework for UDIs. “Regulatory authorities are responsible for developing the UDI [database] in their jurisdiction based upon local policy requirements and the principles developed in the IMDRF UDI guidance and this document,” the document says.
The UDI application guide provides a set of recommendations for developing regional UDI databases (UDID), identifies roles and responsibilities and list considerations for UDI implementation. Yet it recognizes additional guidance may be needed in the future. “As the UDI system matures, it will require ongoing process and data improvements driven by multi-stakeholder efforts to meet both submitter and user requirements,” IMDRF says.
Another new 28-page technical document harmonizes the principles for labeling medical devices and in vitro
diagnostic (IVD) devices, including the content of the label and instructions for use. The final document
also offers labeling principles on devices containing software or software as a medical device, devices intended for laypersons and for information intended for a patient.
The revised document
on IMDRF SOPs updates the adoption process of a new work item proposal (NWIP) and criteria to become a management committee (MC) member or official observer.
The updated adoption process specifies timeframes for the adoption of NWIPs and new timelines on launching new working groups. Application requests to become an MC member or official observer now require two consecutive years in prior participation, down from three years.
Revised 2018 final documents on the marketing clearances of devices
using the ToC format add requirements from Singapore’s Health Sciences Authority and revise the summary definition. The summary of a ToC submission should also address the acceptance criteria, in addition to the four initial areas or purpose, methods, results and discussion and conclusions.
The final ToC assembly and technical guide was posted
soon after the IMDRF MC meeting in March. Annexes E and F to the document
on adverse event terminologies were approved also.