Today, we’re talking about the 6th step in the life cycle of medical devices (MD): Compiling the clinical evaluation report (CER).

Once all essential preclinical and clinical data have been gathered, the next critical phase is compiling the Clinical Evaluation Report (CER). This is the culmination of an extensive process. It brings together all the pieces of your medical device’s technical file, including:

✅ Preclinical and clinical data
✅ The Risk Management File (RMF)
✅ The Device’s Labeling
✅ Instructions for Use (IFU)

These components, along with other key elements, are integrated to show regulators that the device meets the safety and performance standards, such as the MDR (EU Medical Device Regulation). The compiled CER is essential for finalizing technical documentation and obtaining regulatory approval.

BiTrial is an expert in helping companies create comprehensive CERs. Let us help you navigate this important process. Contact us today!