eIFU for Medical Devices: Country Specific Regulations and Benefits

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.

Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is amended by adding at the end the following: “Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.”.

According to Regulation (EU) 2021/2226, Article 3, instructions for use may be provided in the electronic format for the following types of devices, covered by Regulation MDR (EU) 2017/745 and intended for professional use only:

1. Implantable, and active implantable Medical Devices and associated accessories;
2. fixed installed Medical Devices and associated accessories;
3. Medical Devices and associated accessories with an integrated system for displaying instructions for use.

On the other hand, with regards to software covered by MDR, Manufacturers can provide the instructions for use in the electronic format directly via the software itself.

Lastly, the Implementing Regulation requires that Manufacturers make instructions for use available in their websites by indicating on the devices label that IFU are provided in the electronic format instead of the paper one.

Eligible devices are limited to those intended for use by professional users, and not for supply to the general public (i.e. paper-form IFU is required and additional electronic IFU is optional for devices supplied to the general public).

Users should always have the choice to obtain the content of the eIFU in paper form on request, without undue delay or within the time period specified in the risk assessment, and free of charge.

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. The directions for use may include a surgeon’s instruction manual, operator’s manual, or user’s manual.

For devices that are not sold to the general public, this information may be provided as downloadable from the internet and/ or on electronic data storage devices.

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.

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.
The new Japanese regulation eliminates the ability to provide IFU (previously called “Tempu Bunsho”) in physical format for professional users. The new law requires all IFUs to be provided in electronic-only.

MDS – G10: Guidance on Labelling Requirements for Medical Devices, Dated: 18-Jan-2015: Where the device is intended for use by lay persons, the IFU shall be provided in a paper format.

Under the general rule, electronic Instructions For Use (eIFU) are allowed. At the same time, the medical device manufacturer shall ensure they are accessible for potential users of a medical device. Moreover, it should be clear for a potential user how the correct version could be found. Additionally, there should be an option to obtain the IFU in paper format. It is important to mention that eIFU is allowed only for medical devices intended to be used by healthcare professionals, while in the case of medical devices intended to be used by laypersons, the paper format is mandatory.