IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices
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.
Other components of the proposed document that help understand the applicability of custom-made device exemptions include the clarifications that adaptable devices are mass-produced and that raw materials for additive manufacturing are not regulated as medical devices. The appendices also clarify how a “medical device production system” is regulated, if applicable to a jurisdiction, and health institutions’ involvement in point-of-care production of personalized devices—a new and growing trend.
“When certain exemptions or special requirements apply to manufacturing medical devices in health institutions, these only apply to devices intended to address indispensable clinical needs within that institution or its network of subsidiary or partner institutions,” the IMDRF document clarifies. In addition to usual requirements, manufacturers of adaptable devices must provide validated instructions “which explain how to adapt, adjust, assemble or shape the device” and “ensure that the permissible point-of-care changes to the device do not negatively impact the device’s safety or performance.”
The decision tree is followed by overviews of the general requirements on custom-made devices and patient-matched devices as well as manufacturing and record-keeping recommendations for each of the device type. Most recommendations fall under custom-made devices, with additional information about registration and postmarket surveillance.
Manufacturers should keep documentation for all implantable custom-made devices and all implantable patient-matched devices at least 15 years from the date of manufacture and for at least five years for all other custom-made devices and patient-matched devices, the IMDRF WG states.
The consultation opened by the IMDRF WG, which is chaired by Australia’s Therapeutic Goods Administration (TGA), on the proposed document will close on 24 July. It follows on the heels of TGA’s February consultation—closed in March—on a proposed regulatory scheme for personalized devices.
Proposed document