INDUSTRY NEWS

A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) was published in April 2007 by the European Commission and came into force on 1 January 2008. To help manufacturers and distributors navigate the update, Roger Gray, director, global regulatory affairs, at Donawa Consulting (Rome), will host a free webinar devoted to European vigilance procedures on 2 April. The event will be hosted by EMDM sister publication Medical Device Technology, and moderated by editor Annie Ellerton.

The 2007 update provides more guidance than the previous version, introduced in 2001, and 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 webinar will cover all the major revisions, point by point. Topics will include new terms and definitions, the guideline’s extended scope, reporting criteria and timelines, filing safety notices and field safety corrective actions, the vigilance aspects of revising Directive 2007/47/EC, and more. The webinar is designed for regulatory personnel involved in device manufacture or distribution.

At Donawa Consulting, Roger Gray, BSc, CEng, MIMechE, helps clients obtain medical device marketing clearance for Europe and the United States, in addition to managing the firm’s European authorized representative portfolio. He has more than 25 years’ experience in the medical device industry and, as chair of the Association of British Healthcare Industries Technical Committee and a member of the COCIR Technical Committee, was closely involved with the development of the Medical Devices Directives during their formative stages.

The webinar is scheduled for 2 April at 10 am London time. Registration is free of charge at www.devicelink.com/mdt/vigilance_webinar.