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).
