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New and revised documents released by IMDRF


02nd July 2019

Following a meeting in March, the International Medical Device Regulators forum (IMDRF) posted four new documents on unique device identification (UDI) and labeling rules, and four revised documents on standard operating procedures (SOPs), the Table of Contents (ToC) format and adverse events.

Three documents from the four new ones are on UDI. 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.

In the revised document on IMDRF SOPs the adoption process of a new work item proposal (NWIP) and criteria to become a management committee (MC) member or official observer is updated.

The updates include specific timeframes for the adoption of NWIPs and new timelines to launch new working groups. The prior participation required in application requests to become an MC member or official observer is now two years instead of three.

Requirements from Singapore’s Health Sciences Authority were added in the 2018 revised final documents for marketing clearances of devices and IVDs using ToC format.

The final ToC guidelines along with annexures on adverse event terminologies were also published.


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