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Can a product that incorporates nonviable human tissue be regulated as a medical device in Europe? Is a product that includes viable tissues or cells of animal origin regulated as a medical device? Is a product that incorporates a human blood derivative regulated as a medical device? This article discusses the scope of the medical device Directives and the regulatory status of products that are...
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The Medical Technology Evaluation Programme (MTEP) within the National Institute for Health and Clinical Excellence (NICE) was set up in 2009; this is a programme focusing specifically on the selection and evaluation of new or innovative medical technologies (including devices and diagnostics). One of the requirements to enable a product to be evaluated by the MTEP is that the device is CE mark...
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The regulation of medical devices across the world is very varied, ranging from comprehensive to none. Over the past two decades, the number, range, and complexity of medical devices has increased. Regulation of these devices has also evolved due to an increasing awareness of the need for a more consistent approach to regulatory documentation. This will aid both manufacturers selling a product ...
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ژورنال
عنوان ژورنال: BMJ
سال: 1993
ISSN: 0959-8138,1468-5833
DOI: 10.1136/bmj.307.6902.459