Compliance with medical device requirements must be based upon the regulations in force that apply to these products.
Donawa Lifescience Consulting is providing a selection of key regulatory references for Europe, the United States, Japan and China.
For Europe, we have selected the latest consolidated versions of the medical devices directives, including incorporation of the text from the major revising directive2007/47/EC, published in the Official Journal on 21 September 2007. These are the official European Commission consolidated texts, and include the remaining original text and all the subsequent amendments in single documents.
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