The Saudi Food and Drug Authority (SFDA), the country’s regulating authority, has published a guidance document dedicated to the requirements for electronic instructions for use (eIFU) of medical devices. The document was initially published on August 22, 2019, for public comments. The present SDFA guidance is intended to provide additional clarifications regarding the requirements.
Scope of the SFDA eIFU Guidance
According to the document, the scope of the present guidance covers medical devices (including ones intended for in vitro diagnostics) falling within the categories outlined below:
- are intended to be marketed in Saudi Arabia,
- are being accompanied by the instructions for use supplied in electronic form,
- are intended to be used by healthcare professionals.
At the same time, the medical devices intended to be used by the patients themselves and in vitro diagnostic medical devices intended to be used at the point of care are falling outside the scope of the SFDA guidance on eIFU requirements.
The present document is based on the Guidance on Requirements for Medical Devices Listing and Marketing Authorization (MDS-G5) and the Essential Principles set forth therein establishing that the medical devices marketed in Saudi Arabia could be supplied with the instructions for use provided in non-paper (electronic) format.
SFDA eIFU Requirements
The document describes in detail the requirements the electronic instructions for use should meet in order to comply with applicable rules and regulations.
First of all, the medical device manufacturer shall explicitly indicate that the instruction for use is being provided in an electronic form. In particular, such an indicating should be included in the physical information accompanying the device. It is also recommended to indicate the Uniform Resource Locator (URL) with which the eIFU is accessible. In case if the medical device has a built-in screen that displays the eIFU, such information should not prevent healthcare professionals from using the device, especially in the context of the life-monitoring or life-supporting functions.
Before proving the instructions for use in an electronic form, the medical device manufacturer shall conduct a rigorous risk assessment coving the following aspects:
- the level of knowledge and experience of the potential (intended) users regarding the device and the way it should be used,
- the environment in which the medical device in question is intended to be used,
- the level of knowledge and experience of the potential users regarding the way the instructions for use could be displayed,
- the possibility of uninterrupted access of the user to the resources the eIFU is accessible in,
- the measures to be implemented to prevent the data from unauthorized third-party intervention,
- potential situations in which the IFU provided in paper form could be required,
- the potential impact of possible unavailability of the eIFU,
- the estimated time necessary to provide the user with the instructions for use in paper form upon the appropriate request of the user.
The SFDA also mentions that the medical device manufacturer shall duly update the risk assessment described hereinabove on the basis of the information collected in the course of post-market surveillance.
The guidance also describes the requirements related to the information the electronic IFU should contain. According to the document, the instructions for use provided in electronic form should contain:
- the indication of a release date, jurisdiction, and the particular version (the authority also mentions that in case of eIFU provided online, the previous versions should remain available too),
- all mandatory elements required under the Guidance on Requirements for Medical Device Listing and Marketing Authorization (MDS-G5) and the Essential Principles set forth therein.
- if the device has a pre-defined expiry date, the eIFU should remain available for the users within at least 2 years from the expiry date of the last device produced,
- if the device has no pre-defined expiry date, the eIFU should remain available for the users within at least 15 years from the date the last device has been manufactured.
Besides the requirements for the information, the electronic instructions for use should contain, the document also describes the requirements for the website on which the eIFU are made available. In accordance with the present SFDA guidance, such a website should comply with the following requirements:
- the cybersecurity measures implemented should be sufficient to withstand unauthorized third-party intervention,
- the appropriate technical measures should be implemented to ensure the reduction of the possible downtime or display errors to the lowest extent possible,
- the website should contain all previous versions of the eIFUs with the numbers of versions,
- the eIFU should be easily accessible without the need to create an account or to enter a password,
- the particular format the instructions for use are being provided should be commonly used, and the software needed to access it should be freely available,
- the instructions for use approved for the Saudi market should be identified accordingly.
Terms and Definitions
The SFDA guidance on requirements for the instructions for used provided in electronic form contains certain specific terms. In order to assist medical device manufacturers and other parties involved with the interpretation of the information contained therein, the document also contains the definitions of the terms used, namely:
- Layperson – a person having no special training, also refers to a non-professional user,
- In Vitro Medical Device – a device intended to be used for the in-vitro examination of specimens collected from the human body for diagnostic, monitoring, or compatibility purposes, including calibrators, specimen receptacles, special software, etc.,
- Labeling – the information placed directly on the medical device itself or any of its part, or supplied with the medical device,
- Instructions For Use – the information provided by the manufacture to inform the device users of the medical device`s intended purpose and proper use and of any precautions to be taken. The term “eIFU” refers to the same information provided in an electronic form respectively.
Summarizing the information provided here above, the present SFDA guidance describes the requirements the instructions for use provided in electronic form should meet in order to comply with the applicable regulations. In particular, the document outlines the obligations of the medical device manufacturer related to the eIFU, namely:
- the risk assessment to be carried out by the manufacturer when considering the option to provide the IFU in an electronic form,
- the information to be included in the eIFU,
- the requirements the website should meet,
- the requirements regarding the particular format the eIFU should be provided in to ensure accessibility,
- the definitions of the most important term.
According to the document, the medical device manufacturers intended to place their devices on the Saudi market are allowed to provide the instructions for use in an electronic format providing that the medical device in question is intended to be used by healthcare professionals, and the appropriate format of the IFU does not impact the use of the device in a safe and efficient way.
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