A clinical evaluation report (CER) retrieves and appraises clinical data from various sources in order to provide evidence that a medical device is conforming with GSPRS. We have summed up the commonest sources for you.
Download the file here
Tip: Do not forget to provide a rationale for the sources you are using based on your device’s degree of novelty and time on market, findings of previous clinical evaluations, level of inherent risk and overall availability of data.
