New Regulations and Content Requirements for Clinical Evaluation Reports - Notified Body Expectations for Clinical Evaluation Reports
January 20, 2010, 11:00-12:30
via the Web
Chicago, IL
Details
The 2007 amendment to the European Medical Device Directive comes into force in March 2010, and it requires a full clinical evaluation (CE) to be conducted as part of the process to market a device. Since notified bodies will review the results of the evaluation, it is important that the clinical evaluation is conducted appropriately, correctly and robustly. The clinical evaluation determines whether or not a new clinical investigation is required.
Questions will be clarified from a Notified Body perspective-From the British Standards Institute, Dr. Gert Bos and Dr. Suzie Halliday will present the Notified Body expectations and answer questions.
