Critical Considerations in Pharmacovigilance of Medical Devices and In-Vitro Diagnostics

The article highlights the need to expand patient safety efforts beyond medicines and vaccines to include strong vigilance for medical devices and in-vitro diagnostics (IVDs). These technologies are central to healthcare, but their risks often emerge after use in real-world settings. It stresses that device and IVD vigilance must monitor both safety and performance, since malfunctions, false results, software issues, poor maintenance, or user errors can lead to delayed diagnosis, misdiagnosis, or patient harm. The article calls for stronger post-market surveillance systems, better reporting pathways, user feedback, literature screening, trained personnel, and collaboration among regulators, manufacturers, healthcare workers, laboratories, and patients. For Africa, it frames materiovigilance as a key patient safety and market-shaping priority as the continent expands access to health technologies and strengthens regulatory systems.