Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (c. 79)

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ANNEX IU.K.ESSENTIAL REQUIREMENTS

B.DESIGN AND MANUFACTURING REQUIREMENTSU.K.

8.Information supplied by the manufacturerU.K.

8.5.If the intended purpose of the device is not obvious to the user, the manufacturer must clearly state the intended purpose in the instructions for use and, if appropriate, on the label.U.K.