by Medical device vigilance is a process of collecting and reporting information on serious events, field safety corrective actions, and trends in predictable side effects of medical devices. medical device vigilance is a reactive process that is a component of all Post-Market Surveillance (PMS) systems under the MDR.
In Europe, MEDDEV 2.12/1 provides guidance on medical device vigilance reports and how they are filed. It includes details on terminology and timelines. According to the EU Directive on Medicinal Devices, a manufacturer or authorized representative must report any adverse event resulting in death, or serious deterioration of health or that may lead to these consequences. It also requires reporting any incident that results from a malfunction or failure of the device, inadequate instructions for use, or inadequate labeling.
The U.S. Food and Drug Administration (FDA) established the MedWatch electronic medical device reporting system to facilitate the reporting of adverse events associated with devices marketed in the United States. Manufacturers, Medical Device Vigilance user facilities, and device importers are obligated to report these events; healthcare professionals, patients or consumers can also submit voluntary reports.
Depending on the severity and nature of the adverse event, there are several different report types that are required by each regulatory agency. For example, in the United States, the FDA requires manufacturers to report certain reports within 30 days of becoming aware of an event. The FDA also allows a manufacturer to report certain malfunctions in summary form.
The Medical Device Vigilance Market is an integral part of the medical device industry, focusing on patient safety and the continuous improvement of medical devices’ safety and efficacy. Technological advancements and regulatory harmonization are driving the market’s growth, enabling more efficient and effective post-market surveillance practices. As medical technology evolves, the Medical Device Vigilance Market will continue to evolve to meet the challenges and opportunities presented by new and innovative medical devices.
In the United Kingdom, MHRA has a similar program that requires manufacturers to file a report when an adverse event occurs and is deemed to be the result of the device. Moreover, if the adverse event is considered to be an important public health issue, it must be reported within two days of being made aware of it.
As part of its commitment to the US Congress, the FDA introduced a Voluntary Malfunction Summary Reporting (VMSR) program in 2018. This program allows manufacturers to report malfunctions for certain devices in summary form on a quarterly basis instead of in the traditional 30-day MDR report format. In January 2023, The Ministry of Health, Labor, and Welfare of Japan published updates on the sale of used medical devices, simplification of online application procedures and others.
