scope:

This document specifies the requirements for information supplied by the manufacturer for a medical device or accessory, as defined in 3.1. This document includes the generally applicable requirements for identification, marking and documentation of a medical device or accessory. This document does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied.

This document has been prepared to support:

- the essential principles of safety and performance for the information supplied by the manufacturer of a medical device according to ISO 16142-1:2016 (see Annex C); and

- the essential principles of safety and performance for the information supplied by the manufacturer of an IVD medical device according to ISO 16142-2:2017 (see Annex C);

- IMDRF/GRRP WG/N47:2018 [3] (see Annex D); and

- IMDRF/GRRP WG/N52:- [4] (see Annex D).

NOTE Some authorities with jurisdiction impose additional requirements for the identification, marking and documentation of a medical device or accessory.

The requirements of a medical device-specific product standard take priority over this document.