Vigilance
Incident monitoring and reporting for medical devices and IVDs
Vigilance refers to the systematic monitoring, evaluation, and reporting of incidents related to medical devices and in vitro diagnostics after they are placed on the market. QbD Group supports manufacturers in establishing compliant and efficient vigilance systems.
What is vigilance?
Vigilance refers to the systematic monitoring, evaluation, and reporting of incidents related to medical devices and in vitro diagnostics after market placement. It forms part of the post-market surveillance (PMS) obligations under the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
Manufacturers are required to implement vigilance processes to detect, assess, and report serious incidents, field safety corrective actions (FSCAs), and trend reports to the relevant Competent Authorities. Non-compliance may lead to regulatory actions, including recalls or other enforcement measures.
QbD Group supports manufacturers in developing and maintaining vigilance systems aligned with MDR and IVDR requirements, integrated within their broader quality and regulatory framework.
How we support you
Our vigilance experts provide structured support across key areas of the vigilance process.
Vigilance system design
We support the design and implementation of vigilance systems tailored to your organization and product portfolio.
Incident assessment
We support the evaluation of incidents against regulatory reporting criteria and the preparation of compliant submissions.
Authority communication
We support interactions with Competent Authorities, including preparation and submission of incident reports and safety communications.
Root cause analysis
We support root cause investigations and the development of corrective and preventive actions.
Vigilance documentation
We support the development and maintenance of vigilance procedures, templates, and related documentation.
Core vigilance obligations
Under MDR and IVDR, manufacturers must implement processes covering:
Serious Incident reporting
Timely reporting of serious incidents to Competent Authorities within applicable regulatory timelines.
Trend reporting
Identification and reporting of statistically significant trends in non-serious incidents.
Field Safety Corrective Actions (FSCAs)
Planning, coordination, and execution of corrective actions, including communication through Field Safety Notices where applicable.
Vigilance system maintenance
Establishment and maintenance of a systematic process for incident detection, evaluation, and reporting within the PMS framework.
Why QbD Group
Your trusted partner
QbD Group combines regulatory expertise with practical experience in vigilance processes for medical devices and in vitro diagnostics.
Experience supporting vigilance activities under MDR and IVDR.
Practical involvement in incident handling and FSCA processes.
Integrated approach linking vigilance, PMS, and quality management systems.
Flexible support models, from ad-hoc assistance to broader vigilance support.
Training to support internal capability development.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.