The MDR (EU Regulation 2017/745) emphasizes post-market surveillance of medical devices. Vigilance (proactive) and incident reporting (reactive) are key components. Proactive vigilance reporting is encouraged within the industry.
- Vigilance involves systematic monitoring, collection, analysis, and evaluation of device safety and performance .
- Incident reporting focuses on documenting adverse events, near misses, and field corrections.
MDR assigned responsibilities:
- Manufacturers establish and maintain vigilance systems, report incidents, and take corrective actions .
- Importers act as manufacturers regarding vigilance .
- Distributors collaborate with manufacturers on reporting and inform authorities.
- Healthcare providers identify and report adverse events.
Must haves for a good vigilance system:
- Incident definition and classification to detect and respond to incidents correctly.
- Incident reporting procedures for efficient collection and investigation.
- Data management for analysis, trend identification, and reporting.
- Risk management for continuous assessment and mitigation.
- Communication and collaboration among stakeholders for information exchange.
MDR sets reporting timelines based on severity. Serious incidents require faster reporting.
Vigilance is part of post-market surveillance (PMS) to monitor device performance and identify safety issues . UDI (Unique Device Identification) helps track devices and investigate incidents.
Best way to start Vigilance Reporting is:
- Following a Risk-based approach.
- Conducting Data analysis and continuous learning.
- Continuous improvement.
- Collaboration and knowledge sharing.
Effective vigilance and incident reporting are crucial for medical device safety. By adhering to MDR requirements and implementing robust systems, manufacturers can contribute to patient safety and public trust. Not sure where to start? We can help; all these topics require experience to execute and our consultants have the right experience to help you with any vigilance questions.