Medical Device Vigilance

MaterioVigilance Services 

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.

Our MaterioVigilance Expertise

We provide a full range of services for both device clinical studies and post-registration needs.
Our team of vigilance experts are well versed in the differing requirements for CE-marked and non-CE marked devices, Implantable Medical Devices, In Vitro Diagnostic Medical Devices and drug-device combination products following both European Union (EU) MEDDEV guidelines and relevant parts of subsection H on Medical Devices under FDA CFR 21.

Medical Device Vigilance Services:

  • Medical Device Consultancy and Project Management

  • Safety Data Management and Global Safety Database

  • Adverse Device Effect (ADE) and Medical Device Incident (MDI) case processing, coding and follow-up

  • Case narratives

  • Device Vigilance Report preparation and submission

  • Medical assessment

  • ADE/MDI trending and evaluation

  • Literature search and review

  • Vigilance Quality Assurance including SOP development

  • Monthly compliance and status reporting

  • ADE and MDI reconciliation

  • Field Safety Corrective Action (FSCA) generation and submission

  • Creation and distribution of Field Safety Notices (FSNs)

  • Periodic reporting: Development Safety Update Reports (DSURs), IND Safety Reports, Periodic Safety Update Reports/Periodic Benefit Risk Evaluation Reports (PSURs/PBRERs), and Periodic Adverse Drug Experience Reports (PADERs).

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