The Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD 90/385/EEC) have been significantly changed by the European Amended Device Directive (2007/47/EC), and many of these changes are expected to become active in March 2010. Clinical evaluations must follow a well-defined and methodologically sound procedure. In this audio conference, the speaker describes these expectations for clinical evaluations and provides suggested templates for clinical evaluation reports (literature reviews and clinical studies).
This session provides valuable information to Class I and Class IIa medical device manufacturers, who may now be expected to add clinical evaluations to their current technical documentation in the EU. It also provides important insights for regulatory, clinical and quality departments within device manufacturing companies, as well as to CROs and consultants who are assisting these companies with their 2010 compliance preparations.
Clinical Data Requirements under the New MDD & AIMDD is being presented by Dr. Joy Frestedt, President/CEO, of Frestedt Incorporated and airs on Wednesday, October 21, 2009. For more details, or to register please visit our site at www.fxconferences.com
