Apr 17, 2017
EMERGO SUMMARY OF KEY POINTS:
The International Medical Device Regulators Forum (IMDRF) has published a final draft of proposed terminologies for harmonized adverse event reporting for medical devices and IVDs.
The IMDRF document defines terms and codes intended to improve accuracy and effectiveness of adverse event reporting for both industry and regulatory agencies. The proposed terminologies are intended for use by both companies obligated to report adverse events to authorities and by regulators that monitor and analyze such events to protect public health.
The IMDRF’s proposed terms and codes are “readily usable, in contrast to narrative text, for more sophisticated approaches to signal detection…and trending analysis by incident management systems including advanced querying functions and data visualization,” enabling faster responses from regulators and manufacturers.
The IMDRF proposal lists four subsets of terms that would make up the overall adverse event terminology; each subset has its own alphanumeric code. Three of these four components remain under development.
These terminologies are being developed to support reporting of several issues: device-level observations, device components and accessories, patient- or user-level observations, and investigations into causes of an adverse event.
The International Medical Device Regulators Forum (IMDRF) has published new recommended requirements for recognizing device company auditors ahead of an international auditing program pilot launching this year in the US, Canada, Brazil and Australia. Separately, the IMDRF has issued final documents on related topics including auditor training requirements, Unique Device Identification (UDI) and software as a medical device.
The International Medical Device Regulators Forum (IMDRF), the successor organization to the Global Harmonization Task Force (GHTF), is seeking comment through August 2013 on proposed definitions of standalone medical device software. The IMDRF sees these definitions as a first step toward establishing an international framework for more uniform regulatory approaches to medical software.