№ lp_1_29605
This document outlines harmonized terminology and coding for reporting adverse events related to medical devices and in vitro diagnostics, intended to enhance safety monitoring and improve the accuracy of adverse event reporting.
Year: 2019
Region / City: International
Subject: Medical device adverse event reporting
Document Type: Proposed document
Organ / Institution: International Medical Device Regulators Forum (IMDRF)
Author: IMDRF Adverse Event Terminology Working Group
Intended Audience: Regulatory authorities, healthcare providers, manufacturers, reporters of adverse events
Period of validity: Not specified
Approval date: 27th June 2019
Date of Changes: Not specified
Price: 8 / 10 USD
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