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ISO/PWI 24884 Electronic Instructions for Use for In Vitro Diagnostic Medical Devices (Minimum required information and means of delivery)

By December 1, 2023No Comments

Scope

The proposed new standard provides guidelines on the conditions (means of delivery) and minimum required information which shall be physically delivered, when providing electronic instructions for use (eIFU) for in vitro diagnostic medical devices (IVDs).

Not in the scope of this standard: The content of the eIFU as it is covered by ISO 18113-1, -2, -3, -4, -5. This document is applicable to the in vitro diagnostic manufacturers, the developer (investigators), and the users such as medical laboratories. It is also intended to be used by the organizations (e.g. regulatory authorities and conformity assessment bodies), which are responsible for assessing the performance and quality control.

Purpose

At the international level, the use of electronic instructions for use (eIFU) for different types of IVDs continues to expand which creates the need for a harmonized approach for eIFUs in the IVD sector. IMDRF also encourages manufacturers to employ the most appropriate methods of delivering information. Modern technologies enable instructions for use (IFU) and technical information to be provided using a more efficient means of delivery. Information can be digitally encoded on magnetic or optical media, displayed on a screen, incorporated in the device, or even transmitted over the internet at the time of use. While these advances offer users the possibility of more timely availability of critical information, such as performance changes, and offer manufacturers more effective means of disseminating the information, a harmonised approach for a minimum required information and conditions for eIFU delivery (i.e., website availability, data security etc.) is lacking thus far. In a fastdeveloping digital world standardization of eIFU requirements is crucial to promote their safe and effective use across the globe. Therefore, the proposed standard for Electronic Instructions for Use for In Vitro Diagnostic Medical Devices will help manufacturers, users, and regulators to better align on and implement the minimum requirements and means of delivery for eIFUs.

Comment by: 16 January 2024

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