In a new proposal to harmonize regulatory pathways for personalized medical devices, the International Medical Device Regulators Forum (IMDRF) is looking to crack down on the “questionable use of custom-made device exemptions” that some countries have been noticing.
The IMDRF personalized medical devices working group (WG) makes note of technology’s evolution, which has allowed products to be targeted to an individual, as well as the ways in which custom-made devices have been exempted from certain regulations.
“Technology has made ‘custom-made’ devices, including implantable devices for particular patients, within reach on a much greater scale,” the WG says. “Consequently, some jurisdictions are noticing questionable use of custom-made device exemptions; with growing numbers of patients receiving higher risk classification medical devices to meet their particular needs, under these exemptions.”
The 13-page proposed document harmonizes the application of the existing regulatory pathways based on personalized device type by clarifying the requirements for each category specified in the document that IMDRF finalized last October on definitions for personalized devices. The document serves as a “best practice model for harmonizing the regulation of personalized medical devices across international jurisdictions.”
Key to addressing the issues with “questionable use of custom-made device exemptions” is a decision tree to determine the regulatory pathway a device would be subject to, whether it is the regulatory pathway for patient-matched, adaptable or custom-made devices…