What Everybody Needs to Know about Clinical Evaluation Reports?
If you've never written a clinical evaluation report for a medical device, you're probably worried about how involved the report needs to be and how many resources you'll need to complete it. The updated European Medical Device Regulation (MDR), which went into effect in May 2017, includes new, stricter CER reporting criteria. The level of detail contained in a CER, as you might expect, varies depending on the device. A device with higher potential patient risks necessitates a more detailed CER report. The greater the stakes, the more detailed the report must be. However, regardless of how many resources are required to complete a CER report, the structure remains constant. As one of the best CER Consultant providers in the market, Thomas Regulatory Resolutions is always there to help you get the clinical evaluation report done for your medical device quite comfortably. A clinical evaluation report is a complete examination of pre and post-market clinical data pertinen