Vigilance Handling for Medical Devices and IVDs
Stay compliant and safeguard patients with effective vigilance systems. We help you manage complaints, incidents, and CAPA – ensuring timely reporting and continuous improvement under MDR and IVDR.
Vigilance handling is a critical process for medical devices and in vitro diagnostic (IVD) products, ensuring that any incidents, adverse events, or any other potential safety issues are promptly identified, assessed, and reported to the relevant authorities. Effective vigilance systems help manufacturers monitor the real-world performance of their products, respond quickly to emerging risks, and implement corrective actions to protect patient safety.
Vigilance and complaint handling are core obligations under the European Union Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
Complaint handling processes must ensure that every complaint is recorded, investigated, and that findings are incorporated into the continuous improvement of both the device and the manufacturer’s Quality Management System (QMS), as set out in Article 10(9) of the MDR and Article 10(8) of the IVDR. Manufacturers are also responsible for implementing processes for the identification and management of nonconforming products, reporting of incidents, and conducting necessary corrective and preventive actions (CAPA).
By embedding these requirements into your operational procedures—with a strong QMS based on ISO 13485:2016—you will ensure regulatory compliance, enhance patient safety, and maintain access to EU markets.
We support you at every stage
Our services are designed to support you at every stage, from product registration and PMS to vigilance reporting and regulatory updates, allowing you to demonstrate your commitment to compliance and product performance under the EU MDR and IVDR frameworks.