Understanding and Implementing the EU Vigilance System

Why Should You Attend:

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 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.

This webinar will provide the information you need to understand the vigilance document. It explains the various requirement including adverse event reporting, recall notification to regulators, recall notification to customers, trending analysis for complaints, and other areas covered.

Areas Covered in the Webinar:

• 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)

Who Will Benefit:

• Regulatory Managers
• Management Representatives
• Quality Managers
• Compliance Managers
• Notified Body Liaison
• Audit Managers
• Complaint and Incident Specialists

Instructor Profile:

Daniel O'Leary is president of Ombu Enterprises, LLC, a company offering training and execution in operational excellence, focused on analytic skills and a systems approach to operations management. Mr. O'Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Master’s Degree in Mathematics; is an ASQ certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and Six Sigma Black Belt; and certified by APICS in resource management.

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