Medical device reporting: another final rule, Part II.
Part I of this article discussed the chronology of the United States (US) Medical Device Reporting (MDR) regulations, the suspension of the US Designated Agent requirements, and important considerations concerning reporting responsibilities for non-US manufacturers. This article will discuss the contents of the recently published MDR final rule.
Donawa
M
M
Donawa and Associates Ltd, Rome, Italy. donawa@srd.it www.donawa.com
D003625:Data Collection; D004868:Equipment Failure; D004869:Equipment Safety; D006801:Humans; D007221:Industry; D007255:Information Services; D008420:Manufactured Materials / Q000592:standards*; D011640:Public Policy; D014481:United States; D014486:United States Food and Drug Administration