Clinical Evaluation Reports for Medical Devices

Changes have swept European medical device regulations, affecting every company that markets medical devices in Europe. 

The 2007 amendment to the Medical Devices Directive 93/42/EEC came into force in March 2010.  One of the major changes is that every medical device sold in Europe, regardless of its classification, must have a Clinical Evaluation Report (CER) in its technical file. Notified Bodies are requesting that technical files for older devices are updated with a CER.  Given that most medical devices do not have clinical data generated from a clinical trial, the majority of CERs rely exclusively on published information. The major criticism that Notified Bodies have of CERs is that the published information cited is not relevant to the device under scrutiny. New guidance for preparing CERs was issued in 2009 (MedDev 2.7.1/3).

This SME Tool box will educate participants on the change in the Medical Devices Directive, will make them aware of the steps needed to prepare a CER, and describe best practices that will keep Notified Body findings at bay.

To register online for this free event please follow link to the website

http://www.nexxusscotland.com/events/show/1260

or contact Judy Rudd at j.rudd@nexxusscotland.com