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Medical device reporting: another final rule, Part I
1Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
Abstract:
The history of the United States (US) Medical Device Reporting (MDR) Regulation is long and complicated. This has made compliance with the requirements an especially challenging exercise. The publication of a new regulation clarifies some outstanding reporting issues, but not all. Part I of this article includes a chronology of MDR regulations and discusses some requirements that should be of particular interest to non-US companies. Part II will discuss the contents of the new MDR regulation.
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