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Donawa M. Medical device reporting: another final rule, Part I. Med Device Technol. 2000;11(2):40-2
Donawa, M. (2000). Medical device reporting: another final rule, Part I. Medical device technology, 11(2), 40-2.
Donawa, M. "Medical device reporting: another final rule, Part I." Medical device technology vol. 11,2 (2000): 40-2.
Donawa M. Medical device reporting: another final rule, Part I. Med Device Technol. 2000 Mar;11(2):40-2. PMID: 10915493.
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Med Device Technol. 2000 Mar;11(2):40-2.

Medical device reporting: another final rule, Part I.

Medical device technology

M Donawa

Affiliations

  1. Donawa and Associates Ltd, Rome, Italy. [email protected]

PMID: 10915493

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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