IMDRF publishes guidance documents on personalized medical devices for comment
24 November 2022
The International Medical Device Regulators Forum (IMDRF) Personalized Medical Devices Working Group proposes the guidance documents “Personalized Medical Devices – Regulatory Pathways” and “Personalized Medical Devices – Production Verification and Validation”, which are available for public comment until November 28, 2022 and December 28, 2022.
The guidance document, “IMDRF/PMD WG/N58 Personalized Medical Devices – Regulatory Pathways,” is a recommendation for a harmonized approach to apply existing regulatory pathways to medical devices intended for specific individuals. It provides specific considerations for the regulation of each identified category of personalized medical devices (PMDs). A harmonized regulatory approach to the control of these types of medical devices is underpinned by the adoption of consistent, harmonized requirements, offering significant benefits to manufacturers, users, patients, and regulators.
Given the continuous technology development since the publishing of the Global Harmonization Task Force (GHTF) foundation documents, it is now possible to produce medical devices individualized on a commercial rather than technical scale. Manufacturing technologies used to create these PMDs include computer-controlled additive and subtractive manufacturing methods based on patient images. The original GHTF documentation does not adequately address medical devices of this nature.
The term custom-made device has already been defined in many legal systems, with exemptions being introduced for the regulation of custom-made devices. In some countries, exemptions were introduced with the intention, among other things, to keep the number of manufactured custom-made devices at a small scale since they were to be used in special cases only. Today, regulators are faced with a very different environment. Due to the technologies such as additive and subtractive manufacturing, especially when combined with digital patient data, personalized devices, including implantable devices, are much more widely available. A secondary purpose of this IMDRF guidance is to provide some considerations for how the current regulatory frameworks can be adapted to address this evolution in manufacturing practices.
Another guideline already published by IMDRF, “IMDRF/PMD WG/N49 Definitions for Personalized Medical Devices,” establishes harmonized definitions for diverse categories of personalized medical devices, including tailored, patient-matched and customizable medical devices.
The guidance document “IMDRF/PMD WG/N74 Personalized Medical Devices – Production Verification and Validation” is a sequel of the two previously mentioned documents, offering harmonized recommendations regarding verification and validation aspects for a patient-matched medical device and medical device manufacturing system. This document provides pre-market application guidance on verification and validation aspects of the specified design envelope, one of the salient features of a patient-matched medical device defined in the IMDRF/PMD WG/N49 (Definitions for Personalized Medical Devices). The document also provides pre-market application guidance on verification and validation aspects of MDPS, a new concept in the manufacturing of medical devices, introduced in the IMDRF/PMD WG/ N58 (Personalized Medical Devices – Regulatory Pathways).