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4 1. PURPOSE AND PHILOSOPHY OF MEDICAL DEVICE CLASSIFICATION It is not feasible economically nor justifiable in practice to subject all medical devices to the most rigorous conformity assessment procedures available.

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Page 4 of 6 4. REPORTABLE EVENTS UNDER ANNEX 7 AND ANNEX X OF DIRECTIVES 90/385/EEC AND 93/42/EEC RESPECTIVELY. For the purpose of this guidance and based on the definitions above, the following events

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