Changes in Europe: The New Landscape for Existing Medical Devices

Medical Device Link -- According to the European Commission, nearly 8000 types of products, ranging from simple bandages to diagnostic equipment to life-maintaining implantable devices are governed by the European Union’s (EU) medical devices legislation. The regulatory framework comprises three basic medical device directives that have been amended on a number of occasions since their adoption in the 1990s. The most recent technical revision to the directive on active implantable medical devices and Directive 1993/42/EEC, commonly referred to as the Medical Devices Directive (MDD), was introduced through Directive 2007/47/EC.1

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