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Device Vigilance System

The purpose of device vigilance is to collect, assess, and report any incident deriving from the use of a medical device, in order to protect patients and users as well as preventing such incidents from occurring again. Device vigilance is carried out differently depending on the class of the device.

Device classification

Medical devices are classified based on the increasing risk they pose for users.

Less critical, non-active and non-invasive devices belongs to Class I.

Class IIa includes medium risk devices, for example invasive active devices interacting with the body, while Class IIb includes medium/high risk devices, where such interaction can be dangerous.

High risk devices (implantable devices; including medicines or animal derivatives; some of those acting vital organs functions) are included under Class III.

European regulations require that manufacturers set up a vigilance system to collect and investigate all incidents and report them based on the national requirements.

Di Renzo Regulatory Affairs provides a wide range of services to ensure compliance of medical devices with European Regulation through all steps of a device life cycle.

We can take on the role of Responsible person for device vigilance in Italy as well as in other EU Member States and extra-EU countries. Thanks to a net of experienced partners, we can act as point of contact with regulatory authorities all over the world.

We assist MD manufacturers and/or their authorized representatives in preparing and managing notification of incidents and near misses as well in performing the relevant follow-up.

Besides, as our medical devices vigilance unit is part of a broader monitoring system also covering pharmacovigilance for medicines, we can also provide device vigilance for medical devices combined with a pharmaceutical active substance.

Di Renzo Regulatory Affairs offers a wide range of services to deal with Adverse Device Effects (ADE) and Medical Device Incidents (MDI), including their case processing, coding and follow-up, ADE and MDI trending, evaluation and reconciliation.

We can perform ADE and MDI medical assessment and assist companies in preparing and submitting Device Vigilance Reports as well as Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSNs).

We perform specific activities of device vigilance such as literature search and review and safety data management, and we are able to develop Vigilance Quality Assurance systems including drafting and updating SOPs for device vigilance activities.

Foto di Benjamin Sz-J. da Pixabay