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TGA leads IMDRF work on personalised medical devices
The IMDRF PMD Working Group is chaired by Ms Tracey Duffy (First Assistant Secretary, Medical Devices and Product Quality Division, TGA)
The Working Group includes representatives from the following jurisdictions:
- The European Union
- Saudi Arabia
- South Korea
- The United Kingdom
- The United States of America.
Advances in materials science, computing power, imaging, and manufacturing technologies have led to an increase in the design and manufacture of personalised medical devices (PMDs). PMDs are devices intended to meet the specific needs or physical attributes of an individual. The manufacture of PMDs occur at a commercial rather than an individual scale, with manufacturing processes often taking place at the point-of-care (POC). For example, 3D printing in hospitals.
Healthcare professionals with access to new technologies and the devices they produce can lower the cost of healthcare and offer more treatment options, some of which can be lifesaving, to their patients. But the rise of PMDs and the shift towards POC manufacturing brings new risks. These risks are not present for mass-produced medical devices manufactured through traditional facilities. Regulatory oversight of these kinds of devices, in line with the level of risk they present, is required to ensure the device’s safety and performance.
The International Medical Device Regulators Forum (IMDRF) Personalized Medical Devices Working Group is tasked with developing guidance documents and harmonised recommendations for regulating PMDs. Consistent and harmonised requirements for PMDs when adopted by various jurisdictions will offer significant benefits to users, patients, manufacturers, and regulatory authorities in this rapidly growing area of device manufacture.
In 2018, the Working Group published harmonised definitions for various categories of PMDs (pdf,541kb). This publication includes definitions of custom-made; patient-matched; and adaptable medical devices. It also introduced the concept of a 'specified design envelope', a characteristic feature in the patient-matched medical device definition.
In 2020, the Working Group published a further document, Personalized Medical Devices - Regulatory Pathways (pdf,650kb), recommending regulatory pathways for different categories of PMDs. This document introduced an additional framework for a new concept – the medical device production system (MDPS). MDPSs are end-to-end systems comprised of raw materials, software, equipment, and operating instructions. MDPSs are intended to produce PMDs by end users (including health professionals) at the POC.
In February 2021, the Australian Government introduced regulatory reforms for PMDs that broadly align with the IMDRF recommendations in the N49 – definitions for various categories of PMDs and N58 – PMD – Regulatory Pathways) documents.
Following worldwide public consultation in 2022, the Working Group published a technical document in March 2023, Personalized Medical Devices – Production Verification and Validation. This guidance provides technical considerations for the manufacture of patient-matched medical devices and MDPSs. This includes validation aspects of a specified design envelope.
In 2022 the Working Group also revisited the MDPS definition and framework, expanding the MDPS definition to incorporate medical devices other than PMDs. The revised N58 document was open for global public consultation during September-November 2022 and the Working Group is now finalising the document for publication. The proposed changes to the N58 document aligns with the real-world manufacture of medical devices, enabling stakeholders to adopt the MDPS framework.
The Working Group is also developing support and training materials to help with understanding of the concepts presented in the technical documents.