IMDRF Releases New Draft Documents on Personalized Devices, Standards

The International Medical Device Regulators Forum released new consultation documents on personalized medical devices and on optimizing standards for regulatory use following its March meeting in Shanghai.

The IMDRF committee released a new draft on definitions for personalized medical devices, proposed by Australia at the forum’s last meeting in Ottawa. The aim of the consultation is to develop consistent definitions to describe devices that are intended for a particular individual.

“It is now possible to produce medical devices that are individualized, for example, using additive manufacturing (3D printing) methods based on CT scans, on a commercial scale,” the document notes.

The draft makes a distinction between personalized medical devices and custom-made medical devices. It clarifies that patient-specific devices are made by an industrial manufacturing process according to the written request of an authorized healthcare provider but are not considered custom-made. However, an orthopedic implant requested by an orthopedist with specific requirements for an individual patient would be considered a custom-made device.

The guidance also suggests clear definitions for patient-specific devices and adaptable devices. Specific design characteristics refer to unique design specifications based on an individual’s specific anatomy.

IMDRF’s Standards Working Group released a separate consultation document on optimizing standards for regulatory use which the forum believes can help harmonize international standards. The document covers essential principles of safety and performance, as well as the use of consensus standards.

IMDRF also released a final document from its Patient Registries Working Group on tools for assessing the usability of registries in support of regulatory decision making. The document provides guidance to regulators for using patient registries to make decisions on device approvals, expanded indications, and post-marketing surveillance, as well as on performance criteria.

Read the consultation documents here: www.fdanews.com/04-13-18-IMDRFdocs.pdf.