12 September 2017: UL regulatory expert, Sue Spencer speaking on "EU IVDR: Classifications/Performance Evaluation" from 8:30-10:00 am.
Description/Outline of Proposal:
Under the new IVD regulations we will see a quantum leap, currently only 20% of manufacturers needing a Notified Body in the future at least 80% will need a Notified Body. As a result there are many IVDs which have never been reviewed by a Notified Body, some of these products may have been developed some years ago and in addition expectations for clinical evidence continue to increase. This session will include strategies and expectations from both industry and Notified Body on how to deal with the legacy products situations.
- Understanding different legacy scenarios
- Learn what data could be used to support clinical and performance evaluation evidence for a legacy device
- Be able to answer if you need to repeat performance evaluation studies
- Learn approaches for presenting legacy products using existing data to support compliance
Full registration information for the program may be found at raps.org/2017/