On 25 February 2021, changes to the Therapeutic Goods (Medical Devices) Regulations 2002 (‘the Regulations’) commenced to introduce a new regulatory framework (the Framework) for medical devices that are designed and manufactured for individual patients (otherwise known as 'personalised' medical devices).  The key change introduced under the Framework is a change to the definition of a custom-made medical device.

The TGA received a range of feedback and information during the course of introducing the Framework, including concerns from some sectors about the impact of the changes.

In some cases it was claimed that the regulatory requirements were:

• a duplication of existing regulation already provided by professional accrediting bodies or other regulatory bodies;
•  excessive when compared with the actual risk posed by the device; and/or
• unreasonable in terms of regulatory burden.

So in July 2021 the TGA 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. To which CHF submitted the attached response.