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Purpose
This guidance applies to manufacturers of medical devices that are regulated as system or procedure packs and supplied using the special conformity assessment procedure regulatory pathway.
Separate guidance is available to assist manufacturers of Class I or Class 1 IVD system or procedure packs to make this declaration using a different template. See Guidance for declaration of conformity procedures for more information.
This document is to assist manufacturers of system or procedure packs in completing the declaration of conformity made under clause 7.5 for system or procedure packs (other than a Class I or Class 1 IVD system or procedure pack).