April 17, 2023 Medical Device - Clinical

There are several benefits of using electronic Instructions for Use (eIFU) labeling for medical devices, including:

1. Accessibility: eIFUs can be accessed from anywhere with an internet connection, making them more accessible than paper-based instructions.

2. Timeliness: eIFUs can be updated more easily and quickly than paper-based instructions, ensuring that users always have access to the most up-to-date information.

3. Cost savings: eIFUs can help reduce costs associated with printing, shipping, and distributing paper-based instructions.

4. Environmental benefits: eIFUs can reduce paper waste and the environmental impact associated with the production and disposal of paper-based instructions.

5. User-friendliness: eIFUs can include interactive features such as videos, animations, and hyperlinks, which can make them more user-friendly and easier to understand than traditional paper-based instructions.

Overall, eIFUs offer a more convenient, efficient, and sustainable way to provide instructions for use of medical devices, while also improving accessibility and user experience.

eIFU Requirements for In Vitro Diagnostic Devices in Various Countries

following eIFU
eIFU Required for IVD? Comments
USA Yes Required labeling for prescription devices intended for use in health care facilities or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of law, and that the manufacturer affords such users the opportunity to request the labeling in paper form, and after such request, promptly provides the requested information without additional cost.
Europe Optional Implementing Regulation (EU) 2021/2226 on electronic instructions for use does not apply to in vitro diagnostic medical devices (IVDs). For them, the IVDR governs when manufacturers may deviate from the paper form:

“When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic), except when the device is intended for near-patient testing.”

IVDR (Regulation 2017/746) Annex I, Chapter III, 20.1.f

Australia Optional Note: IFUs may not be supplied exclusively in electronic form for IVD medical devices intended for near-patient testing (i.e. at the point of care); paper-form IFU must also be provided.
Canada Optional As it pertains to the electronic labelling (e-labelling) of certain medical devices not sold to the general public Health Canada considers e-labelling to refer to the information required by section 21(1) of the Regulations that would ordinarily be found in the directions for use.
Brazil Yes with some exceptions listed in Article 2 Article 5. The instructions for use provided in non-printed formats shall contain:
I – all information required in item 3.2 of the Annex of RDC 206, of November 17th, 2006, if invitro diagnostic products;Article 2. It is hereby forbidden to provide instructions for use exclusively in non-printed
formats for the following products:
I – healthcare equipment intended for:
a) overall domestic use, including those intended for use in homecare services (SAD); and
b) being operated by laypeople, regardless of the location;
II – healthcare materials used by laypeople;
III – in-vitro diagnostic products, comprising:
a) self test products;
b) products used for remote laboratory testing; and
c) patterns and calibrators.
Japan Yes In particular, for medical devices and in vitro diagnostics, posting the package inserts on the website, which had not been required, is now mandatory.

Marketing Authorization Holders (MAHs) must register the information on the Safety Information Posting System located on the PMDA’s website for MAHs. For information on how to register medical devices in the system and post the electronic package inserts, please refer to this information PDF.

Learn more about the benefits and requirements of eIFU labeling for medical devices.