A few important postmarketing vigilance revisions are now being implemented. One of these is the revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5), which came into force on January 1, 2008.
Offering greater clarity and more guidance than the previous version, the new document includes new reporting terminology and many new concepts. It has also excised or added new, important terms.
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.
An understanding of the nitty-gritty of the reporting procedure
A webinar that seeks to clarify on all these areas is being organized by Compliance4All, a very well-known provider of professional trainings for all the areas of regulatory compliance. David Dills, Global Regulatory Affairs & Compliance Consultant, who has an accomplished record with more than 26 years of experience within Regulatory Affairs, will be the speaker at this webinar. To gain understanding of the important aspects of post-marketing vigilance reporting, please register by logging on to http://www.compliance4all.com/control/w_product/~product_id=500836
Understanding of the new definitions and much else
At this session, David will help participants understand the ways by which they can make sense of these new definitions. He 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. David will also describe the European Database EUDAMED.
He will also offer clarity on some of the controversial aspects of the new guidelines. The extension of their scope and the new approach of immediate reporting unless delays can be justified are some of these.
These areas of controversy, however, have got mollified somewhat with additional clarity and more detailed advice in many areas. Since certain GHTF concepts got integrated, periodic or trend reporting under certain conditions is now allowed. The revised guidelines will undoubtedly result in the need for manufacturers, authorized representatives, and distributors to make changes to their SOPs and other documents, although a transition period was allowed until the end of 2007.
David will cover the following areas at this webinar:
o Examine the latest changes to MEDDEV and Medical Device Vigilance and impact on medical device manufacturers
o Recognize the “new” terminology and concepts
o Report incidents as recommended by the guidance
o Examine why Global Harmonization Task Force (GHTF) is an integral component of the new postmarketing vigilance guidelines
o Manage expectations for reporting and timelines
o Recognize which amendments impact the European vigilance system
o Interpret the new guidelines that cover incidents involving devices that carry the CE mark and devices that do not carry the CE mark
o Submit periodic summary reports of incidents to Competent Authorities
o Examine controversial aspects of the guidelines, including the extension of their scope and the new approach of immediate reporting unless delays can be justified
o 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