E-documentation

e-documentation covers websites, downloads and on-device help. In the EU, electronic instructions for use are allowed only for the devices and conditions set in Regulation (EU) 2021/2226.

any form of electronically accessible information supplied by the manufacturer (3.10) related to a medical device or accessory (3.1) EXAMPLE CD/DVD-ROM, USB stick, website. Note 1 to entry: See Figure 1.

ISO 20417:2021, clause 3.6