Topics
- Recognize the "new" terminology and concepts
- Examine the latest changes to MEDDEV and Medical Device Vigilance and impact on medical device manufacturers
- Examine why Global Harmonization Task Force (GHTF) is an integral component of the new postmarketing vigilance guidelines
- Report incidents as recommended by the guidance
- Recognize which amendments impact the European vigilance system
- Manage expectations for reporting and timelines
- Submit periodic summary reports of incidents to Competent Authorities
- Interpret the new guidelines that cover incidents involving devices that carry the CE mark and devices that do not carry the CE mark
- Identify the conditions under which reporting is not required and why they have been expanded and clarified with no significant changes, although one reason has been removed
- Examine controversial aspects of the guidelines, including the extension of their scope and the new approach of immediate reporting unless delays can be justified
Who should Attend
Attendees from device companies in involved in vigilance reporting, including Regulatory Affairs, management and departmental representatives, Quality and Compliance, Clinical Affairs, Distributors, Marketing & Sales, Consultants and Engineering/Technical Services/Operations.
