Marking

Marking is part of the label but sits on the device, not the packaging. A UDI direct mark is one kind of marking.

information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical device or accessory Note 1 to entry: For the purposes of this document, the term marked is used to designate the corresponding act. Note 2 to entry: For the purposes of this document, marking is different from “direct marking” as commonly described in unique device identification (UDI) standards and regulations. A UDI “direct marking” is a type of marking. Note 3 to entry: See Figure 1. [SOURCE: ISO 20417:2021,[15] 3.16]

ISO 15223-1:2021, clause 3.11

information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical device or accessory (3.1) Note 1 to entry: For the purposes of this document, the term marked is used to designate the corresponding act. Note 2 to entry: For the purposes of this document, marking is different from ‘direct marking’ as commonly described in unique device identification (UDI) standards and regulations. A UDI ‘direct marking’ is a type of marking. Note 3 to entry: See Figure 1. [SOURCE: ISO 18113-1:2009[8], 2.4, modified — replaced ‘permanently’ with ‘durably’, deleted notes and added Note 1 to entry and 'or accessory'.]

ISO 20417:2021, clause 3.16