Accompanying information

ISO 15223-1 and ISO 20417 use accompanying information as the umbrella term: label, marking, instructions for use and e-documentation all sit under it, and it counts as part of the device. Promotional material is a separate category.

information accompanying or marked on a medical device or accessory for the user or those accountable for the installation, use, processing, maintenance, decommissioning and disposal of the medical device or accessory, particularly regarding safe use Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory. Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical description, installation manual, quick reference guide, etc. Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types (e.g. CD/DVD-ROM, USB stick, website). Note 4 to entry: See Figure 1. Note 5 to entry: The label can include the information on the packaging of the medical device. Note 6 to entry: e-documentation can include any or all types of information supplied by the manufacturer partially or entirely. Note 7 to entry: Marketing information is also known as promotional material. Note 8 to entry: There is guidance or rationale related to accompanying information in ISO 20417:2021,[15] Annex A. [SOURCE: ISO 20417:2021,[15] 3.2, modified — The following text has been removed from the graphic: “Scope of ISO 20417”, defined term reference numbers and a side box containing information outside the scope of ISO 20417. Note 8 to entry has been added.]

ISO 15223-1:2021, clause 3.1

information accompanying or marked on a medical device or accessory (3.1) for the user or those accountable for the installation, use, processing, maintenance, decommissioning and disposal of the medical device or accessory, particularly regarding safe use Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory. Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical description, installation manual, quick reference guide, etc. Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types (e.g., CD/DVD-ROM, USB stick, website). Note 4 to entry: See Figure 1. Note 5 to entry The label can include the information on the packaging of the medical device. Note 6 to entry e-documentation can include any or all types of information supplied by the manufacturer partially or entirely. Note 7 to entry Marketing information is also known as promotional material.

ISO 20417:2021, clause 3.2