The global medical device vigilance market is estimated to grow significantly, at a CAGR of 8.7%, during the forecast period owing to the government regulations on the post-market surveillance of medical devices. The healthcare industry is nearly incomplete without medical devices. Such a wide presence of medical devices in one of the major industries of the globe poses certain requirements for its harmonization. Therefore, the reporting of medical devices problems is required, some of these problems include malfunctioning of medical devices which sometimes leads to serious injuries or deaths.
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There are several countries that have regulated the medical device vigilance system in their healthcare infrastructure. The US, Europe, and South-Asian countries such as India, Thailand, China, and others have harmonized legislation on medical devices. The government of these countries ensures that the stated procedures are applied at every stage in their healthcare sector. Such involvement of governmental bodies in regulating the medical devices insistently drives the growth of the global medical device vigilance market.
United States — Medical Device Reporting (MDR) – 21 CFR Part 803
Under Medical Device Reporting, the incidents in which a device may have contributed or caused severe injury should be required to report to the FDA. Moreover, some malfunctions must also be reported. It is a mechanism for manufacturers and FDA to evaluate and monitor significant adverse events concerned with medical devices. The objectives of the regulation are to correct and detect problems in a timely manner.
The mandatory MDR regulation (21 CFR 803) covers important requirements for producers, importers, and device user facilities (such as hospitals) to report some device-associated adverse events as well as product concerns to the FDA. The reports should be filed in an electronic equivalent format on FDA Medwatch Form 3500A. Moreover, the manufacturers are needed to report to the FDA after knowing that their devices may have contributed or caused serious injury or death. They also have to report to the FDA in case of malfunctioning of the device that likely to cause or contribute to serious injury or death. Importers are required to report to the manufacturer and the FDA in case, when one of their devices may have contributed or caused severe injury or death.
European Union — MEDDEV
The European Medical Devices Directive (93/42/EEC) and In-Vitro Diagnostic Devices Directive (98/79/EC) state that medical device manufacturers are legally required to report adverse events and Field Safety Corrective Actions (FSCAs) to EU Competent Authorities. It is mandatory for medical device manufacturers to report vigilance issues in line with the European Guidelines on a Medical Devices Vigilance System (MEDDEV 2.12/11).
Moreover, the device manufacturers are required to implement a systematic procedure to review experience gained from devices and ensure that any problems associated with the use of their device are identified at an early stage and are reported to competent authorities so that appropriate action is taken at a proper time.
Global Medical Device Vigilance Market- Segmentation
By Delivery Mode
- On-Demand
- On-Premise
By End-User
- Contract Research Organizations (CROs)
- Business Process Outsourcing (BPO)
- Original Equipment Manufacturers (OEM)
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