Donawa Maria
Donawa & Associates Ltd, Rome, Italy.
Med Device Technol. 2004 Dec;15(10):30-1.
By the spring of 2005, the European Commission hopes to present the first draft of the revisions to the Medical Device Directive to the European Council and Parliament. However, these revisions represent only part of the changing European regulatory scenario. This article discusses a tangible shift in European medical device regulatory policy and some actions that companies can take to understand and prepare for these policies.
到2005年春天，欧盟委员会希望向欧洲理事会和议会提交医疗器械指令修订案的初稿。然而，这些修订只是不断变化的欧洲监管形势的一部分。本文讨论了欧洲医疗器械监管政策的切实转变以及公司为理解和应对这些政策可以采取的一些行动。
