Glossary

any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity

[FDA 21CFR1]

a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

Note: The term "immediate container" does not include package liners.

[OLRC 21USC9]

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 2017/745]

written, printed or graphic information provided upon the medical device itself

[ISO 15223-1:2016]

all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce

Note: The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.

[FDA 21CFR1]

all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

[OLRC 21USC9]

label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents

[ISO 13485:2016]

an individual who does not have formal education in a relevant field of healthcare or medical discipline

[EU MDR 2017/745, EU IVDR 2017/746]

all phases in the life of a medical device, from the initial conception to final decommissioning and disposal

[ISO 13485:2016, ISO 14971:2019]