Medical Device Vigilance System Is An Important Part Of Medical Industry To Verify Safety And Health Of Public

Medical device vigilance is vital for the safety of the public, as well as the health of patients. Under European Union law, all serious incidents relating to the use of a medical device must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA aims to improve vigilance and post-market surveillance by introducing a signal detection process for detecting trends and signals in vigilance data, such as changes in known risks. This approach is a valuable resource for manufacturers who wish to achieve a better understanding of the risks and benefits of their products and to comply with the latest regulatory requirements. However, serious incidents relating to devices outside the EU market are not included in EU vigilance. The purpose of medical device vigilance is to detect and respond to adverse events associated with the use of medical devices. These incidents can include misuse or improper application of a device and may cause death or serious deterioration of health. As such, any incident relating to a medical device must be reported to the national competent authorities. Nevertheless, there are a number of steps that manufacturers can take to comply with EU guidelines.

In Europe, the GHTF has worked to implement a uniform regulatory framework for medical devices, however, significant differences between national regulations continue to hinder the introduction of new technologies. The European Union (EU) has published a new guideline for the development of a universal vigilance system. This guidance includes updating the MHRA's 'Manufacturer's Incident Report' form. This form should be used for all serious incidents that arise under the MDD and the EU MDR.

Moreover, medical device vigilance involves a process called materiovigilance. It is the first step in post-market surveillance of a medical device. The process relies on complaints, and the manufacturer does not take specific actions until they have learned of a specific incident. As such, a robust system of complaint management is vital to fulfilling the vigilance reporting system. For instance, the manufacturer must submit a report to the NCA after it becomes aware of a reported event. In July 2019, the European Commission (EC) announced the issue guidance on the medical device vigilance system under the medical device directive of EU.