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Description and specification, including variants and accessories of the in vitro diagnost...

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Device description and product specification, including variants and accessories 2.1 The d...

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(b) the intended user (lay person or professional); (c) a general description of the princ...

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(b) If the in vitro diagnostic medical device contains any of the following then descripti...

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(i) for medical devices intended to emit ionizing radiation, information on radiation sour...

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e) a description of the accessories, other medical device and other product that are not m...

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2.0 Device description and product specification, including variants and accessories 2.1 T...

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2.0 Device description and product specification, including variants and accessories 2.1 T...

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The device master file should include the following device descriptive information:— (a) i...

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