The newly revised European Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) come into effect on March 21, 2010. There is no transition period, which means that medical devices placed on the market or put into service as of that date will be expected to comply with the revised directives. Some of the most important revisions concern clinical data and clinical evaluation, and the types of adverse events that must be reported if they occur during the clinical study.
In this audio conference, the speaker reviews these changes to the directives, their relationship to ISO 14155, and explores effective ways to prepare for compliance.
Preparing for Increased European Clinical Data and Evaluation Requirements is being presented by Dr. Maria Donawa, President, of Donawa Lifescience Consulting and airs on Thursday, October 8, 2009. For more details, or to register for this audio conference, please visit our site at www.fxconferences.com
