The revised MEDDEV 2.12-1 Rev 5 guidance regarding medical device vigilance was issued in April 2007, and came into effect on January 1, 2008. Whilst not legally binding, this guidance does reflect EU competent authority expectations, and companies are advised to build their vigilance system around the guidance, which needs to be fully understood. For example, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). Examination of the patient reveals movement in the joint, demonstrating lack of fusion. Is this a reportable event?
In this session the speaker reviews the guidance, explains some key definitions and responsibilities, provides a vigilance process map and examines the criteria for reporting, using several examples. Event trending is also discussed, and how to make sense of the information that is delivered via the vigilance system.
Medical Device Vigilance in the EU: Reporting Requirements & Event Trending is being presented by Helen Colquhoun, MD, CEO, with Pleiad Devices and airs on Tuesday, September 22, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
