TGA join the electronic age with electronic IFU
Last week saw an increased number of guidance’s released by the Australian regulator, the Therapeutic Goods Administration (TGA). This included a new guidance on Electronic Instructions for Use – eIFU For professional users of medical devices (including IVDs).
This guidance was pulled together after consultations with industry and considering positions of other regulators.
The published guidance provides clarity around the use of e-Instructions for use by manufacturers via electronic form, being the device “help” systems, or graphical user interface (GUI)-based dialogues, contained in portable electronic storage media supplied by the manufacturer together with the device, or online, through a manufacturer’s website.
Although the guidance does provide manufacturers with an alternative to provide the required information in accordance with Australian Essential Principles, it must be understood that this can only be utilised in specific circumstances. Specifically taking into consideration the users of the specific devices.
The ability to provide forms in electronic form is appealing from a document control perspective, but the manufacturer is responsible for ensuring the electronic form remains available to users for at least 5 years or the lifetime of the device. For obsolete devices, the IFU must remain available during the document retention period as required above and clearly indicate the dates during which the obsolete device was supplied and when the electronic IFU becomes unavailable to the users. This period is longer again for an implantable device.
Download the PDF document with full details.
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