The Medical Devices Directive (MDD), which sets down the rules and regulations for marketing medical devices in the EU, is in the final stages of a lengthy revision process. The general consensus is that the directive has been working well to date, but that certain aspects need to be tightened up. To this end, there are no radically new requirements, but there will be an increased demand for clinical data and post-market surveillance. What will this mean for medical device manufacturers?
In this audio conference, Dr. Helen Colquhoun summarizes the revisions and describe in detail those with the greatest potential impact. She discusses the implications of these revisions for medical device manufacturers, illustrating points with practical examples and using different scenarios to explain how best to approach the issues raised.
The Revised MDD: Practical Implications for Devices was recorded on 2006-02-23 and is available for download at www.fxconferences.com
