What is the purpose of Medical Device Vigilance?
Medical device vigilance, as known as materiovigilance, is the collection, assessment, reporting and identification of trends in incidents resulting from the use of medical devices. Its primary purpose is to protect and improve safeguards for patients, users and others by preventing or reducing the likelihood of reoccurrence of incidents elsewhere.
Within the European Union (EU), medical devices are CE marked and categorised into device classes (Class I, II and III) where different regulations and guidance is followed around the registration and surveillance depending on the class of the device.
A proactive and comprehensive vigilance system is required to be in place by the manufacturer of certain medical devices to ensure all incidents are captured, collated, investigated and, where applicable, reported per national and regional requirements. Furthermore, where devices are used in combination with active pharmaceutical ingredients, it is important that the surveillance system is meeting the regulatory requirements of both the drug and device component where the marketing authorisation holder is also the manufacturer of the device component.