The International Medical Device Regulators Forum (IMDRF) has raised concerns about the "questionable use of custom-made device exemptions" in a draft harmonization proposal.
Harmonized regulatory texts predate the emergence of custom, 3D-printed medical devices, resulting in a patchwork of national approaches that IMDRF fears are being misused.
To address the problem, IMDRF has designed a decision tree to determine the suitability of products for custom-made device pathways.
The medical device landscape today is very different from the one IMDRF's predecessor, the Global Harmonization Task Force, faced when it wrote its foundational documents. Back then, early documents failed to set out a harmonized approach to such products because they were not yet a prominent part of the device terrain.
National agencies have filled the gap by creating exemptions sparing custom-made devices from certain regulations. U.S. regulations limit eligibility to products that are used in no more than "five new custom device cases per year." Yet, according to IMDRF, which lists the U.S., Europe and 10 other countries as members, said similar exemptions are being used more expansively in some parts of the world.
"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," IMDRF wrote in a draft text about custom-made device pathway.
IMDRF used the rest of the draft text to set out how it aims to harmonize approaches to oversight of custom-made devices and curtail some of those exemptions. A regulatory pathway decision tree is central to that effort.
The decision tree poses a series of questions to determine the appropriate pathway for a device. To be eligible for the custom-made pathway, a product must meet multiple criteria that assess if it is designed to suit an individual patient's features under the oversight of a healthcare professional rather than a device manufacturer.
Another section of the document sets out the general requirements for custom-made devices. IMDRF is proposing to recommend that production of higher risk custom-made devices, such as permanent implants, take place at facilities subject to third-party oversight.
IMDRF is accepting feedback on the draft until July 24.