IMDRF Releases Guidance on Personalized Devices
The International Medical Device Regulators Forum (IMDRF) has released a draft guidance that lays out regulatory pathways for personalized medical devices.
The guidance recommends applying existing regulatory pathways to medical devices intended for a particular individual, while also identifying special considerations for regulating each category of medical devices.
The IMDRF Personalized Medical Devices Task Group noted that current guidance fails to take into account recent developments in the device industry such as commercial scale 3D printing methods based on patient CT scans.
Because custom-made devices are now available on a much larger scale, some jurisdictions are noticing questionable use of custom-made device exemptions, with more patients receiving higher risk classification medical devices.