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Consultation: Proposed refinements to the regulation of personalised medical devices

19 July 2021

This consultation closed on 14 July 2021.

Regulatory changes introducing a new framework for the regulation of personalised medical devices commenced on 25 February 2021, including a transition period for eligible manufacturers and sponsors until 1 November 2024.

During the implementation phase a number of sectors have raised concerns over the impact of the new framework including comments that the new regulatory requirements are:

  • a duplication of existing regulation already provided by professional accrediting bodies or other regulatory bodies;
  • the classification of certain requirements for some devices were excessive compared with the actual risk posed by the device; and/or
  • the regulatory burden associated with compliance is unreasonable.

We sought feedback on potential refinements to the Framework that could be considered to ensure risks associated with personalised medical devices are appropriately mitigated without imposing unnecessary administrative and regulatory burden.