Medical device reporting: another final rule, Part I.
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.
Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
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D004864:Equipment and Supplies / Q000592:standards*; D019983:Guideline Adherence / Q000331:legislation & jurisprudence* / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration