You are here

TGA leads IMDRF work on personalised medical devices

20 October 2021

The IMDRF PMD Working Group is currently chaired by Ms Tracey Duffy (First Assistant Secretary, Medical Devices and Product Quality Division, TGA) and includes members representing the following jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Russia, Saudi Arabia, Singapore, South Korea, the United Kingdom and the United States.

The International Medical Device Regulators Forum (IMDRF) PMD Working Group is tasked with developing guidance documents and recommendations for harmonising the regulation of PMDs. The adoption of consistent and harmonised requirements for PMDs across various jurisdictions will offer significant benefits to users, patients, manufacturers and regulatory authorities.

Advances in materials science, computational power, imaging and manufacturing technologies have made it possible to produce medical devices designed to meet the specific needs of particular patients. These personalised medical devices (PMDs) are now manufactured at a commercial scale, rather than individually. Manufacturing processes for medical devices are also shifting closer to the point of care (for example, 3D printing in hospitals), which brings numerous advantages to patients and healthcare professionals.

Timely access to these technologies and devices can be life-saving in some situations, allow healthcare professionals to offer better treatment options to their patients and bring down the overall cost of healthcare. The emergence of PMDs and point-of-care manufacturing is also associated with new risks, however, which did not exist for traditional mass-produced medical devices. Regulatory oversight of the production of these devices, commensurate with the level of risk they present, is required to ensure their safety and performance.

The working group's next guidance document will include technical considerations for production validation of PMDs. The first half of this guidance will provide technical considerations for validation aspects of a specified design envelope for the manufacture of patient-matched medical devices. The second half will cover technical considerations for validation aspects of a medical device production system (MDPS), which is a new concept for regulating point-of-care manufacture of PMDs. Australia is the first jurisdiction in the world to introduce the MDPS definition in its regulations.

The PMD Working Group began collaboratively developing the new guidance at a teleconference in December 2020 and has made steady progress despite COVID-19 travel restrictions. The group has met three times in 2021, and expects to submit the final working draft to the IMDRF Management Committee in early 2022 to seek approval for worldwide public consultation.

In 2018, the working group published harmonised definitions for various categories of PMDs (pdf,541kb): custom-made; patient-matched; and adaptable medical devices. This publication introduced the concept of the 'specified design envelope', a characteristic feature in the definition of a patient-matched medical device. In 2020, the working group published another document, Personalized Medical Devices - Regulatory Pathways (pdf,650kb), which recommended regulatory pathways for different categories of PMDs. In February 2021, the Australian Government introduced regulatory reforms for PMDs that broadly aligned with the IMDRF recommendations in these two documents.