Proposed regulatory scheme for personalised medical devices, including 3D‐printed devices

On 13th February 2019, the TGA opened the consultation: Proposed regulatory scheme for personalised medical devices, including 3D‐printed devices. The proposed changes set out in this consultation, as stated by the TGA, “seek to better regulate personalised medical devices, including the introduction of new definitions”. This consultation follows on from an earlier public consultation and public forums in 2017 and 2018, to which MTAA has also provided feedback.