A new framework for medical devices that are designed, manufactured or otherwise adapted for particular individuals- referred to, as personalised medical devices- will commence on 25 February 2021. This new framework changes how many custom-made medical devices are regulated, including pedorthic devices such as custom shoes or orthoses.
The new regulatory framework will affect anyone who manufactures, imports or supplies personalised medical devices. You should read the guidance published on the Therapeutic Goods Association (TGA) website to understand how the new framework will impact your business.
Overview of the personalised medical devices framework
The new framework:
- reduces the scope of the existing definition of a custom-made medical device;
- introduces new definitions for ‘patient-matched’ and ‘adaptable’ medical devices;
- changes the existing exemption for custom-made medical devices to:
- require annual reporting of custom-made devices supplied in the previous financial year;
- require documentation about the device to be retained for 5 years (for non-implantable devices) or 15 years (for implantable devices);
- require manufacturers to provide information about each custom-made medical device to the intended recipient; and
- allow the TGA to inspect production facilities;
- introduces the new concept of a Medical Device Production System (MDPS) and a framework for regulating these systems to allow healthcare providers to produce personalised devices for treating their patients, without the need for manufacturing certification; and
- updates the classification rule for medical devices that record diagnostic images to include a broader range of technology now used for the purposes of recording patient images for diagnosis and investigation, including anatomical models.