Division 6.1
United Kingdom
The application shall enable the design of the device to be understood and shall enable conformity with the design-related requirements of the directive to be assessed.
It shall include:
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test reports including, where appropriate, results of studies carried out with lay persons,
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data showing the handling suitability of the device in view of its intended purpose for self-testing,
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the information to be provided with the device on its label and its instructions for use.