Table 2.

Risk management processes for non-active implantable medical devices and medicines

	NAIMDs	Medicines
AE Coding	Product problem: FDA and ISO Patient Outcome: SNOMED, MedDRA®, ICD, FDA	MedDRA®
Signal management process	Signal detection, signal validation, signal prioritization, signal escalation, regulatory actions and connections with other processes not as clearly regulated	Signal detection, signal validation, signal prioritization, signal escalation, regulatory actions clearly regulated
Benefit–risk analysis	Underdeveloped, RMF	PSURs/PBRERs, RMPs
Regulatory actions	Withdrawal, Recall, Restriction, Ban, DFU update, Dear Doctor Letter (USA), Field Safety Notice (EU)	Withdrawal, SmPC update, black box warning, Dear Doctor Letter

AE adverse event, DFU directions for use, FDA US Food and Drug Administration, ICD International Classification of Diseases, ISO International Organization for Standardization, MedDRA Medical Dictionary for Regulatory Activities, PBRER periodic benefit–risk evaluation reports, PSUR periodic safety update reports, RMF risk management file, RMP risk management plan, SmPC Summary of Product Characteristics, SNOMED Systematized Nomenclature of Medicine