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The dynamicity and growth of the medical devices market, in terms of numbers of devices sold and in limitless variation in design, assures that medical devices play a huge and important role in healthcare branch. However the medical device regulatory framework, including three key medical device directives (93/42/EEC, 90/385/EEC and 98/79/EC), is too complex and rigid to handle medical device technology advancement and increased requirements for public health and safety. This work is researching the EU medical device regulatory framework including the development background of this regulatory framework, the current legislative situation and insight into possible future legislation with the aim of providing a practical overview and analysis for manufacturers and authorities looking to overcome this regulatory framework complexity.

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Aiste Kirkutyte is a young regulatory affairs professional with vast working experience in medical device field.

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