Implementing ruleIllustrative imageElectronic instructions for use for medical devices
Lays down the conditions under which instructions for use may be supplied in electronic form instead of on paper.
The regulation defines when a manufacturer may provide instructions for use in electronic form, either as an alternative to paper or, for certain device categories, as the default format. Devices intended for use by lay users generally still require a paper version on request.
Manufacturers using electronic instructions must operate a system that gives users access to the current version, provides a paper copy free of charge on request within a defined period, and records when the electronic version was last updated.
The content must remain identical to the version assessed during conformity assessment, and the electronic format must be accessible, including for users with disabilities. Where the device is used in a setting without reliable network access, a paper copy must still be supplied.
The regulation also covers implant cards, which must be provided in a format that patients can carry and read. Manufacturers are expected to align the format with the language requirements of each member state where the device is supplied.
Important: this page is an editorial summary for demonstration purposes. It is not legal advice and does not replace the official text. Always rely on the consolidated version published in the Official Journal of the EU and on qualified regulatory advice.