This document specifies requirements for medicinal product safety alerting systems and topics relevant to suppliers of alerting systems. This document applies to Clinical Decision Support Systems (CDSS), whether they are medical devices or not.

This document covers:

• Requirements for terminology used in medicinal product safety alerts.
• Requirements for the selection of a knowledge base for medicinal product safety alerting systems.
• Requirements for proper CDSS functionality related to medicinal product safety alerting systems.
• Requirements for displaying medicinal product safety alerts.
• Requirements for quality measurement to enhance the effectiveness of medicinal product safety alerts.

The following is beyond the scope of this document:
• Development of content (rule-based knowledge bases) for CDSS.
• Development of algorithms for generating medicinal product safety alerts in CDSS.
• Development of alert processors for medicinal product safety alerts in CDSS.