Objectives of the Presentation
Why Should you Attend
- An overview of the EU Vigilance System
- The role of MEDDEV documents in the EU system
- The conditions that require an EU adverse event report
- The timing of adverse event reports, including their classification
- Developing Periodic Summary Reports to help reduce the quantity of reports
- Trending of complaints and required reporting after recognizing a "signal"
- The two elements of recalls - the Field Safety Corrective Action (FSCA) and the Field Safety Notice (FSN)
This webinar provides the understanding and tools you need to for an effective QMS implementation. Have you fully implemented the current version of the EU's vigilance system? Your Notified Body will check at the next audit. The requirements are extensive and even though the current version became effective in July 2013, many device manufacturers still have gaps. The problem is compounded for device manufacturers that serve the US market, because the requirements are not harmonized.
One major difference is the concept of indirect harm, where devices that do not act directly on the individual. This has specific application to in-vitro diagnostic (IVD) and other devices. The changes that resulted in the current version include in-vitro fertilization (IVF) and assisted reproductive technologies (ART) devices.
The Vigilance document is extensive, covering adverse events, recalls, and complaint analysis. This means the device manufacturer needs to implement a comprehensive approach that will cover many elements of the Quality Management System (QMS).
Understanding the many elements in the Vigilance document will help you create an effective QMS - one that will stand up to a Notified Body audit. But to do this you need to recognize all of the elements in the document. In addition, they won't line up nicely with the corresponding US or Canadian regulations.
Who can Benefit
- Regulatory Managers
- Management Representatives
- Quality Managers
- Compliance Managers
- Notified Body Liaison
- Audit Managers
- Complaint and Incident Specialists
An implementation checklist for the vigilance system