The International Medical Device Regulators Forum (IMDRF) has released a draft guidance laying out regulatory pathways for personalized medical devices.
The IMDRF recommendations represent best practices for harmonizing the regulation of personalized medical devices across international jurisdictions.
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 3D printing methods based on patient CT scans.
Many regulatory authorities have already defined the term “custom-made” device and have introduced exemption provisions for regulating custom-made devices to cover special cases when mass-produced devices did not meet the needs of individual patients.
Because custom-made devices, including implantable devices for particular patients, are now available on a much larger scale, some jurisdictions are noticing the questionable use of custom-made device exemptions, with more patients receiving higher risk classification medical devices under these exemptions.
The working group had previously released a final guidance that defined personal medical devices and distinguished between personalized medical devices and custom-made medical devices. Personalized devices describe devices intended for a particular individual, but custom-made devices are not patient-matched, the guidance says (IDDM, Nov. 16, 2018).
The new guidance includes a decision tree for determining whether a device is a personalized medical device or not and which pathway it should take.
Makers of custom-made devices should determine the classification of the device if it were not custom made, the group suggests. For higher-risk custom-made devices such as implantable devices, manufacturing should be undertaken in a facility that is subject to third-party oversight, the group said.
The group recommends that custom-made devices and their manufacturers be registered or notified to regulatory authorities where they are supplied.
Read the IMDRF guidance here: www.fdanews.com/06-07-19-imdrf.pdf.