This document specifies requirements for information supplied by the manufacturer of IVD instruments intended for self-testing. This document also applies to apparatus and equipment intended to be used with in vitro diagnostic (IVD) instruments for self-testing. This document can also be applied to accessories. This document does not apply to a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; c) IVD instruments for professional use.