Information supplied by the manufacturer

MDCG treats this information as part of the device. That is why inadequate information can be an incident, and why promotional statements count toward the intended purpose.

information related to the identification and use of a medical device or accessory, in whatever form provided, intended to ensure the safe and effective use of the medical device or accessory Note 1 to entry: For the purposes of this document, e-documentation is included in information supplied by the manufacturer. Note 2 to entry: For the purposes of this document, shipping documents and promotional material are excluded from information supplied by the manufacturer. However, some authorities having jurisdiction (defined in ISO 16142-1:2016,[9] 3.1) can consider such supplemental information as information supplied by the manufacturer. Note 3 to entry: The primary purpose of information supplied by the manufacturer is to identify the medical device and its manufacturer, and provide essential information about its safety, performance, and appropriate use to the user or other relevant persons. Note 4 to entry: See Figure 1. Note 5 to entry: There is guidance or rationale related to information supplied by the manufacturer in Annex A. [SOURCE: ISO 20417:2021,[15] 3.10, modified — The cross-reference in Note 2 to entry has been added. Note 5 to entry has been added.]

ISO 15223-1:2021, clause 3.6

information related to the identification and use of a medical device or accessory (3.1), in whatever form provided, intended to ensure the safe and effective use of the medical device or accessory Note 1 to entry: For the purposes of this document, e-documentation is included in information supplied by the manufacturer. Note 2 to entry: For the purposes of this document, shipping documents and promotional material are excluded from information supplied by the manufacturer. However, some authorities having jurisdiction can consider such supplemental information as information supplied by the manufacturer. Note 3 to entry: The primary purpose of information supplied by the manufacturer is to identify the medical device and its manufacturer, and provide essential information about its safety, performance, and appropriate use to the user or other relevant persons. Note 4 to entry: See Figure 1.

ISO 20417:2021, clause 3.10

The information supplied by the manufacturer should be regarded as part of the medical device or accessory. For the purpose of this document, this information includes the label (packaging or marking), instructions for use, technical description, installation manual, quick reference guide, training material, any promotional material, sales material, statements by the manufacturer and other information accompanying the device.

MDCG 2023-3 Rev.2, Question 1, footnote 4