The Medical Devices Introductory Course 2020

Vigilance

Periodic Summary Reporting

Is an alternative reporting regime agreed between the MANUFACTURER and the National COMPETENT AUTHORITY for reporting similar INCIDENTs with the same device or type in a consolidated way where the root cause is known or an FSCA has been implemented or well documented and common

Trend Reporting

A reporting type used by the MANUFACTURER when a significant increase in events not normally considered to be INCIDENTs has occurred and for which pre- defined trigger levels are used to determine the threshold for reporting

The Organisation for Professionals in Regulatory Affairs

Vigilance

Trend Reporting - codes

Terminologies for Categorised Adverse Event Reporting (AE codes) were designed (by the IMDRF) for use in reporting incidents enabling a quantitative evaluation and trending of post-market signals. AE codes, designed by IMDRF, assigned to different: • Event-types • Types of investigation • Investigation findings • Investigation conclusions • Patient outcome (Clinical signs, symptoms, and conditions + Health impact) • Component codes Help can be found in the guidance document.. New manufacturer incident report helptext