204. Deputy Pádraig Rice asked the Minister for Health if the use of MAGEC rods left to fuse in situ beyond two years in patients under the care of Children’s Health Ireland (CHI), contrary to the manufacturer’s instructions for use, was treated as off-label use under EU Medical Devices Regulation (MDR) 2017/745; if CHI ensured that a documented clinical justification was made; if families received written information explaining the off-label use and associated risks; if specific informed consent was obtained in line with legal obligations under MDR and national policy; and if she will make a statement on the matter. [24706/25]

Summary

204. Deputy Pádraig Rice asked the Minister for Health if the use of MAGEC rods left to fuse in situ beyond two years in patients under the care of Children’s Health Ireland (CHI), contrary to the manufacturer’s instructions for use, was treated as off-label use under EU Medical Devices Regulation (MDR) 2017/745; if CHI ensured that a documented clinical justification was made; if families received written information explaining the off-label use and associated risks; if specific informed consent was obtained in line with legal obligations under MDR and national policy; and if she will make a statement on the matter. [24706/25]

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• Medical Aids and Appliances

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