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The Active Implantable Medical Devices Regulations 1992
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1. The manufacturer shall, before the start of manufacture, prepare and submit to the notified body documentation defining the manufacturing process, in particular as regards sterilisation, and all the routine, pre-established procedures to be implemented to ensure homogeneity of production and conformity of the devices with—
(a)the type described in the EC type-examination certificate; and
(b)the relevant requirements of the Directive.
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