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.
When we hear about pharmacovigilance, medicines and vaccines naturally take the center stage. Reasonably so. Over the years, systems for detecting, assessing, understanding and preventing medicine-related adverse effects have been the focus.
Yet patient safety extends far beyond medicines!
Every day, healthcare systems rely on medical devices and in-vitro diagnostics. From rapid diagnostic tests and glucose monitors to ventilators and pacemakers, infusion pumps and surgical equipment, these technologies play a critical role in prevention, diagnosis, treatment and monitoring of various disease states.
Recognizing this reality, World Health Organization (WHO) and the International Medical Device Regulators Forum (IMDRF), have emphasized vigilance and post-market surveillance as essential components of medical device and IVD regulation throughout a product's lifecycle.1 And as observed, medical device regulation is increasingly moving beyond pre-market approval towards lifecycle oversight, across many global markets.
Why? Because approval is not the end of a product's safety story.
Once a device enters the real world, new information can emerge. A device may malfunction. A diagnostic test may generate an unexpected false result. A software update may introduce a new risk. A manufacturing change may affect performance. User experience may also reveal risks that were not apparent during development or evaluation.
Unlike medicines, vigilance for medical devices and IVDs must focus on both safety and performance. Imagine, an IVD generating a false result, getting a sudden update or malfunctioning? These can lead to delayed diagnosis or worse misdiagnosis- yea, the outcome is fatal! (pun intended of course or to be honest sometimes literally). In many cases the greatest risk is not whether a product causes harm directly but, whether it provides inaccurate information that can trigger a cascade of inappropriate clinical decisions.
Safety and performance are not only influenced by product quality but also by user training, maintenance practices, environmental conditions, software functionality and increasingly, cybersecurity considerations.
This is where post-market surveillance and vigilance become critical.
Secondly, in medical devices and IVDs vigilance, user feedback is gold!
Effective vigilance depends on creating channels through which this information can be received, reported, investigated and acted upon. Marketing Authorization Holders (MAHs), Local Technical Representatives (LTRs), distributors, authorized medical representatives, regulators, healthcare professionals, laboratories, procurement teams and patients, are valuable sources of safety information. Therefore, having efficient reporting pathways, stronger data systems, trained personnel and collaboration across borders can turn individual reports into intelligence that protects many more patients.
Another, critical piece is literature screening.
The market is where products meet real patients, real environments and real-world use. Continuous monitoring allows you to identify emerging risks, investigate root causes and implement corrective actions.
What have other MAHs reported regarding a particular device?
Has a user ever complained about sudden malfunction?
Literature screening, not only complements other data sources but can also support important decision making when it comes to IVDs and medical devices’ vigilance.
Africa’s life science market has experienced significant growth in recent years and continues to expand. Africa is not simply importing more health technologies. The continent is increasingly pursuing local manufacturing, regulatory harmonization, reliance and stronger health-product systems.
Yet regulatory capacity remains uneven.
A 2024 WHO African Region assessment found that while most countries have national regulatory authorities responsible for medical devices and IVDs, only 11 of 40 responding countries (27.5%) reported having the full set of elements for post-market surveillance and vigilance systems. Data we will validate through our ongoing regulatory landscape assessment for medical devices and in- vitro diagnostics. The WHO African Region's new 2026–2035 Regional Strategy on Regulation of Medical Products reinforces the need for stronger regulatory systems covering medicines, diagnostics and medical devices.2
The question, therefore, is not whether medical devices and IVDs need vigilance. They certainly do!
It is whether we are giving vigilance the same strategic attention across health technologies that we have historically given medicines.
Mainstreaming vigilance for medical devices and IVDs means moving beyond simply reacting to incidents. It means building systems that can capture complaints and adverse events, investigate device-related problems, identify signals, assess risks, communicate safety information and implement corrective actions.
This is not merely a compliance opportunity. It is a market-shaping opportunity.
As Africa expands access to medical technologies and strengthens its regulatory architecture, vigilance can become part of how the market defines quality not something merely added after a problem occurs or as a compliance checkbox.
The future of patient safety cannot be built around medicines alone.
Medical devices and IVDs are increasingly central to healthcare delivery. Their risks, performance and real-world use therefore deserve equally deliberate attention.
For regulators, manufacturers, healthcare professionals and other stakeholders, the time is right to build the systems, capabilities and partnerships needed to make vigilance for medical devices and IVDs an integral part of patient safety in Africa.
The opportunity is clear: let us mainstream vigilance across the medical devices and IVDs lifecycle.
1 Terminologies for Categorized Adverse Event Reporting: https://www.imdrf.org/documents/terminologies-categorized-adverse-event-reporting-aer-terms-terminology-and-codes
2 African health ministers adopt new strategy to bolster medical regulatory systems: African health ministers adopt new strategy to bolster medical regulatory systems | WHO | Regional Office for Africa