WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.2.4-NRA-vigilance: NRA: run a reporting system for adverse events from manufacturers, users and patients, forward reports for investigation, assess risks, exchange information with other NRAs, issue safety alerts and publish a notices repository

What does 6.2.4-NRA-vigilance require?

From the basic level onward, the NRA should let users, patients and manufacturers (directly or via representatives) report adverse events, incidents and complaints, pass reports it receives to the manufacturer or representative for investigation and trending, conduct its own risk assessments where needed, and exchange information with other NRAs on serious public health threats or trends. It should have a procedure to issue information notices and safety alerts directly to health care facilities and users (discussing the text with the manufacturer where possible, but deciding itself), targeted to those affected, with a public repository, monitor the effectiveness of manufacturers' corrective actions, and be ready to answer the public, clinicians, media and government. At the expanded level it should define mandatory reporting thresholds, time limits, content and responsible parties consistent with WHO and IMDRF guidance.