Overview: Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) came into force on January 1, 2008. Providing more guidance than the previous version, the new document includes new reporting terminology and concepts such as "periodic summary reporting" and "trend reporting." In addition, the terms "advisory notice," "near incident," and "recall" have been eliminated or replaced. Although MEDDEVs are not legally binding, it is likely that all European Competent Authorities will follow the new guidelines and will expect organizations involved in the management and reporting of adverse incidents to follow them as well. This session will address topics such as new definitions; the guideline's extended scope, reporting criteria/timelines, filing safety notices and field safety corrective actions, and more. The new guidelines contain some controversial aspects, including the extension of their scope and the new approach of immediate reporting unless delays can be justified. However, they also provide additional clarity and more-detailed advice in many areas. The European Database EUDAMED also is described. Areas Covered in the Session:Examine the latest changes to MEDDEV and Medical Device Vigilance and impact on medical device manufacturersRecognize the "new" terminology and conceptsReport incidents as recommended by the guidanceExamine why Global Harmonization Task Force (GHTF) is an integral component of the new postmarketing vigilance guidelinesManage expectations for reporting and timelinesRecognize which amendments impact the European vigilance systemInterpret the new guidelines that cover incidents involving devices that carry the CE mark and devices that do not carry the CE markSubmit periodic summary reports of incidents to Competent AuthoritiesWho Will Benefit:All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overviewRegulatory AffairsClinical AffairsQuality and ComplianceMarketing & Sales DistributorsEngineering/Technical Services/OperationsConsultantsDavid R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape.Price: $245.00GlobalCompliancePanelUSA Phone:800-447-9407Fax: 302-288-6884