Materiovigilance
Incident monitoring and reporting for MD & IVD
Materiovigilance is the systematic monitoring and reporting of incidents related to medical devices and IVDs after market placement. QbD Group helps manufacturers build compliant and efficient vigilance systems.
What is materiovigilance?
Materiovigilance is the systematic monitoring and reporting of incidents related to medical devices and in vitro diagnostics after they have been placed on the market. It is a legal obligation under both the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
Manufacturers must establish robust vigilance systems to detect, evaluate, and report serious incidents, field safety corrective actions (FSCAs), and trend reports to the relevant Competent Authorities. Failure to comply can result in regulatory sanctions, product recalls, and reputational damage.
QbD Group helps manufacturers build and maintain vigilance systems that are compliant, efficient, and integrated with their broader quality and regulatory framework.
How we support you
Our vigilance experts provide end-to-end support to ensure your organization meets all materiovigilance obligations under MDR and IVDR.
Vigilance system design
We design and implement vigilance systems tailored to your organization's size and product portfolio.
Incident assessment
We evaluate incidents against reportability criteria and prepare compliant submissions.
Authority communication
We manage all communications with Competent Authorities, including incident reports and periodic safety updates.
Root cause analysis
We support root cause investigations and corrective action planning.
Vigilance documentation
We establish and maintain all required vigilance documentation, SOPs, and templates.
Core vigilance obligations
Under MDR and IVDR, manufacturers must address the following vigilance requirements:
Incident reporting
Timely reporting of serious incidents to Competent Authorities within regulatory deadlines.
Trend reporting
Statistical analysis and reporting of trends in incidents that individually may not be reportable.
Field Safety Corrective Actions
Planning and executing FSCAs, including Field Safety Notices to affected parties.
Vigilance system maintenance
Establishing and maintaining a systematic process for incident detection and evaluation.
Why QbD Group
Your trusted partner
QbD Group combines deep regulatory expertise with practical vigilance experience across medical devices and IVDs.
Experienced vigilance professionals with MDR and IVDR expertise.
Proven track record in managing incident reports and FSCAs.
Integrated approach linking vigilance with PMS and quality management.
Scalable support
from ad-hoc incident handling to full vigilance outsourcing.
Training programs to build internal vigilance competence.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.