August, 2018, Symonston, Australia. Australia’s TGA (Therapeutic Goods Administration) issued a guidance on electronic instructions for use (eIFU) for medical devices earlier this month.
Similar to current EU requirements, Australian regulations require all medical devices to include labeling, instructions for use, and, when applicable, a patient implant card and information leaflet. According to the just released guidance, only professional use devices are eligible for eIFU, and consumer/OTC devices supplied to the general public and IVDs must include a paper copy of the IFU.
When permitted, the electronic IFU must clearly state the date of release, and target regulatory jurisdiction and should be version controlled. Changes implemented in each version (i.e. version history) should be documented for review by the TGA if requested. For online IFUs, obsolete versions of the IFU must remain accessible to the public where appropriate. Information in the electronic IFU must include all items specified in essential principle 13.4 of the MD Regulations, and must comply with all other applicable Australian laws. Any information on software and hardware requirements needed to display the instructions for use must be readily available. The design and functioning of any instructions for use in electronic form must be verified to ensure the electronic document opens and functions correctly.
For a free copy of the guidance, click here. As SaMD and Digital Health Apps almost always have some eIFU component, why not let CRO Group help make your eIFU regulatory experience a solid conforming one. For a no-cost, no-obligation review of your eIFU plans, click here or, if you’re in the Boston area and to enter our monthly raffle to:
WIN A PAIR OF TICKETS
TO A BOSTON CELTICS GAME
Like us to find out how
