Label
To comply with ANNEX I, CHAPTER III, Requirements regarding the information supplied with the device of the European Medical Device Regulation (MDR 2017/745), the UI must include specific information to identify the device and its manufacturer.
According to Annex I, Chapter III (General Safety and Performance Requirements), section 23.1:
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user.
Ensure the UI provides clear identifying details about the device and manufacturer.
Gran Vía 1, 48001, Bilbao, Spain
Version 1.1.0.0
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Consequences of Missing Labeling
According to Article 16 of the MDR 2017/745:
Cases in which obligations of manufacturers apply to importers, distributors or other persons
A distributor, importer, or other person shall assume the obligations of manufacturers if they:
(a) make the device available on the market under their name, trade name, or trademark, unless the manufacturer is clearly identified on the label.
Failure to include required information may result in being considered the manufacturer, with associated legal responsibilities.
Source Code for Symbols
ISO 15223-1:2021, the international standard for medical device symbols, provides a comprehensive list of symbols used in medical device labeling.
Furthermore, icons are also widely available in open source libraries, such as medical-device-symbols, which provides a collection of SVG icons for medical devices that can be directly used in web applications.