Provision of technical support for Australian customers
In Proposal 11, we propose to introduce requirements (under EP 13.4(3) Item 1) for manufacturers of IVD devices to include, in the instructions for use, contact details to allow users to obtain technical assistance. This is based on alignment with EU IVDR GSPR 20.4.1. As such, it is important that Australian sponsors of IVD devices have appropriate agreements in place with their manufacturer/s to ensure an appropriate level of technical assistance is available to Australian customers. This would be especially important for IVD devices intended for self-testing and point of care testing.
Current Regulation 10.2 - Information for Sponsors
(1) The sponsor of a medical device must ensure that the sponsor’s name and address are:
(a) provided with the device in such a way that a user of the device can readily identify the sponsor; and
(b) located in accordance with clause 13.2 in Schedule 1.
(2) If the sponsor of a medical device arranges for a label to be attached or affixed to the device for the purpose of complying with subregulation (1) or for any other purpose (for example, to comply with a labelling requirement under the law of a State or Territory), the label must not in any way adulterate the device or obscure the information provided with the device by the manufacturer.
