Episode description
RQM+ Vice President of Global Regulatory Affairs (and former BSI), Jaishankar Kutty, Ph.D., discusses the process of reviewing clinical evaluation reports (CERs) by notified body reviewers under the EU MDR in our newest video clip.
In the end and more than anything, manufacturers must provide a clear and comprehensive story in their CERs to facilitate the review process. 📖
Highlights:
- Notified body reviewers play a crucial role in the review process of clinical evaluation reports (CERs) under the MDR.
- Manufacturers should appreciate the challenges faced by notified bodies and provide clear and comprehensive information in their CERs.
- The review process is time-constrained, and reviewers rely on sampling and calibration to navigate through the documentation.
- Different reviewers may generate different questions based on their background and experience, but the goal is to enable an effective review of the CER.
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