Following up on a proposal from Australia’s Therapeutic Goods Administration, the International Medical Device Regulators Forum released a new consultation on personalized medical devices following its March meeting in Shanghai.
The aim of the consultation is to develop consistent definitions to describe devices intended for a particular individual.
“It is now possible to produce medical devices that are individualized, for example, using additive manufacturing (3D printing) methods based on CT scans, on a commercial scale,” the document notes.
The draft makes a distinction between personalized medical devices and custom-made medical devices. It clarifies that patient-specific devices are made by an industrial manufacturing process according to the written request of an authorized healthcare provider but are not considered custom-made.
The guidance also suggests clear definitions for patient-specific devices and adaptable devices. Specific design characteristics refer to unique design specifications based on an individual’s specific anatomy (IDDM, April 16).