Label

The label is only part of the information that goes with a device. In the US, everything else that accompanies it is 'labeling', a wider term that includes manuals and some promotional material.

‘label’ means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;

EU MDR, Article 2(13)

‘label’ means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;

IVDR, Article 2(13)

<medical device, accessory> written, printed or graphic information appearing on the item itself, on the packaging of each item, or on the packaging of multiple items Note 1 to entry: For the purposes of this document, the term labelled is used to designate the corresponding act. Note 2 to entry: Label includes the marking on the medical device or accessory. Note 3 to entry: For the purposes of this document, information indicated on a graphical user interface (GUI) is considered as appearing on the item. Note 4 to entry: See Figure 1. [SOURCE: ISO 20417:2021,[15] 3.12]

ISO 15223-1:2021, clause 3.8

<medical device, accessory> written, printed, or graphic information appearing on the item itself, on the packaging of each item or on the packaging of multiple items Note 1 to entry: For the purposes of this document, the term labelled is used to designate the corresponding act. Note 2 to entry: Label includes the marking on the medical device or accessory. Note 3 to entry: For the purposes of this document, information indicated on a graphical user interface (GUI) is considered as appearing on the item. Note 4 to entry: See Figure 1. [SOURCE: IMDRF/GRRP WG/N52: 2019[4], 3.17, modified –added notes and replaced ‘unit’ and ‘devices’ with ‘item’.]

ISO 20417:2021, clause 3.12

The term “label” means a display of written, printed, or graphic matter upon the immediate container of any article.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology

The EU definition covers information on the device itself, on each unit's packaging and on packaging of multiple devices. The FDA definition, from the FD&C Act, covers matter on the immediate container; other accompanying material is labeling.