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 are now seeking 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.
Consultation
This consultation, including the consultation paper, were published on the Department of Health consultation hub.
