Over 1,000 notified body applications per month. Will your device be among them?
Do the math: Regulation 2023/607 The MDR was created under the assumption that manufacturers would be able to switch from the AIMDD and MDD to the MDR during their normal certification cycle. However, it took years before the first notified body was designated and the designation process is still ongoing, supporting structures, like EUDAMED, expert … Read more
