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Classification Rules for Medical Devices

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HtlaeH fo tnemtrapeDnoigeR evitartsinimdA laicepS gnoK gnoH eht fo tnemnrevoGanihC fo cilbupeR s elpoeP tnemtrapeD gnitnirP eht yb detnirP)repap delcycer no kni yldneirf yllatnemnorivne htiw detnirP( Technical Reference: TR-003Date of Issue: 4 Jan. 2010ehTfoehtTechnical Reference: TR-003 Classification Rules for Medical Devices Table of Contents 1. Introduction ........................................ ........................................ ............ 1 2. Scope ........................................ ........................................ ...................... 1 3. Definitions and Abbreviations.

- 2 - 5. Recommendations 5.1 Primary Recommendation The manufacturer should document its justification for placing its product into a particular

  Product, Classification

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