eIFU for Med Devices: Country Specific Regulations & Benefits

eIFU for Medical Devices: Country Specific Regulations and Benefits

September 10, 2024 | Regulations

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.

Countries following eIFU	eIFU Required for MD?	Comments
USA	Yes	Required labeling for prescription devices intended for use in health care facilities or by a health care professional Required 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.” New Update – Acceptable Media for Electronic Product User Manuals As per New Update on August 20, 2024 the CDRH may require a manufacturer of a radiation emitting electronic product to provide to the ultimate purchaser performance data and other technical data related to safety of the product. These data are typically contained in user manuals that accompany electronic products. For example, 21 CFR 1020.30(h) and1040.10(h) specify information manufacturers must provide to users of diagnostic x-ray and laser products respectively with IFU. With the availability of electronic information storage and display technology, many commercial product manuals are being provided electronically. Electronic documentation saves storage space, reduces paper consumption, increases accessibility, and provides rapid means for editing and updating of content. For these reasons, manufacturers can provide the required user information in PDF format. Manufacturers may provide the required information as a web site download, on a compact disc (CD) or on other storage media in common use (e.g., USB external drive), so long as it is made available directly to the purchaser of the product. If the product purchaser is unable to access the electronic version provided, the manufacturer must make the required documentation available in hard copy (e.g., printed paper) at no additional cost. The manuals in whatever form provided should be in the English language.
Europe	Optional	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. For in vitro diagnostic medical devices (IVDs): 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. Users: Professional users only for a, b and c, consumer and professional users for d. Requirements: Risk assessment to be undertaken. Label to indicate that the IFU is supplied electronically, rather than paper. Paper must be available. Must maintain current and historical eIFU on their website for more than 15 years.
Australia	Optional	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). active implantable medical devices and their accessories implantable medical devices and their accessories fixed installed medical devices medical devices and their accessories fitted with a built-in system visually displaying the Instructions for Use standalone software. 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.
Canada	Optional	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.
Brazil	Yes (with some exceptions listed in Article 54 of RDC No. 751)	Article 54 The exclusive availability of instructions for use in non-printed format for the following products is prohibited: I – equipment for use in healthcare that is indicated for: a) domestic use in general, including use in home care services – SAD; It is b) operation by lay people, regardless of the place of use. II – materials for health use used by the lay public. 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. 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.
Saudi Arabia	Optional	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. Guidance on Requirements for Medical Device Listing and Marketing Authorization (MDS-G5) specifies: Instructions for use may be provided to the user in non-paper format (e.g. electronic) 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.
South Korea	Optional	MFDS notification 2018-500. This notification amended the Medical Device Act to specifically call out that providing required labeling via the internet is permitted. No other requirements were included in the notification, but only products which are specifically permitted per the notification may be eLabeled. Home-use labeling may not be eLabeled.
India	Optional	As Per CDSCO MDR 2017 the manufacturer must submit the instructions for use or electronic instructions for use to the Central Licensing Authority (CDSCO) as a part of registration process. In some cases, the CDSCO can request additional information regarding to eIFU. The eIFU should be in format that is easily accessible to users and must contain all the necessary information related to device. The Manufacturer must ensure that the eIFU is updated regularly and must submit eIFU to Central Licensing Authority (CDSCO) as part of the registration process. India does not have specific regulations for electronic instructions for use (eIFU). As Per G.S.R. 30, which went into effect on January 15, 2019, Electronic IFUs are now accepted by the CDSCO. As amended vide GSR 777(E) dt. 14-10-2022(w.e.f. 14-10-2022) which amended the Medical Devices Rules, 2017. These amendments allow manufacturers to provide either paper-based IFU or eIFU. Instructions for use can be provided as an electronic format downloadable from the internet.
Singapore	Optional	GN-23: Guidance on Labelling for Medical Devices – Dated: March 2020: For devices that are not sold to the general public, instructions for use may be provided to the user either in paper or non-paper format. They may be supplied by various means either with the medical device or separate from it. Examples are information downloadable from the internet and/or on electronic data storage devices (compact disc, digital video disc, USB flash drive, etc.).
Malaysia	Optional	MDA/GD/0026: REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES – Dated: 21 November 2022 Stated that: Electronic IFU (e-IFU) is eligible for devices that are limited to those intended for use by professional users only. Paper-form IFU is required and additional electronic IFU is optional for home use devices.