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Paragraph 1

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

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.