Search the Elsmar Cove!
**Search ALL of** with DuckDuckGo including content not in the forum - Search results with No ads.

MDR review process by notified body - How many steps exist in the review process


We are a manufacturer of a Class III medical device, marketing in Asia, US as well as EU.

Question: Do you know exactly how many steps exist in the review process of a medical device by notified body (from application to certification)?

Based upon my past experiences through a number of reviews with our notified body, their steps of review process seems to be as shown below:

Review by scheme manager -> Review by clinical oversight team -> Review by internal clinician -> Panel 1 review -> Panel 2 review -> Expert panel review(from MDR) -> Certification

Is your NB's process similar to above? Otherwise, are the steps of review different depends on each NB? If something is different, could you kindly indicate where is different?

Can anyone here shed some light on any of the above?
Last edited:
Top Bottom