Personalized Medical Devices (PMD)

Working Group Chair(s)
Tracey Duffy
Therapeutic Goods Administration (TGA)
Australia
Membership
Regulators, Regional Harmonization Initiatives, Official Observers
Status
Current

Advances in materials science, computational power, imaging and manufacturing technologies have made it possible to produce medical devices that are designed to meet the specific needs of a particular individual (i.e. personalized medical devices or PMDs). The manufacturing processes for PMDs is also shifting closer to the point-of-care (such as 3D printing in hospitals), which brings numerous advantages to patients and healthcare professionals. However, new risks have also emerged with PMDs and point-of-care manufacturing, which did not exist for traditional mass-produced medical devices.

The purpose of this Work Item is to develop guidance documents for providing harmonized recommendations for the regulation of PMDs. The adoption of consistent and harmonized requirements for PMDs across various jurisdictions will offer significant benefits to users, patients, manufacturers, and regulatory authorities.

The Working Group is currently developing an IMDRF Technical Document which will provide recommendations for production validation of PMDs. The document will provide technical guidance on:

  • Validation of the specified design envelope that is one of the defining features of a patient-matched medical device
  • Validation of a Medical Device Production System (a relatively new framework for regulating point-of-care manufacture of PMDs introduced in the IMDRF/PMD WG/N58 FINAL:2020)
Technical/Informational document

Participants

Adriana David
National Administration of Drugs, Foods and Medical Devices - Argentina
Dr Marcela Rizzo
National Administration of Drugs, Foods and Medical Devices - Argentina

Rebecca Bateson
Therapeutic Goods Administration (TGA)
Uphar Chamoli
Therapeutic Goods Administration (TGA)

Adriano Soares da Silva
Brazilian Health Regulatory Agency (ANVISA)
Joao Henrique Campos de Souza
Brazilian Health Regulatory Agency (ANVISA)
Maria Angela da Paz
Brazilian Health Regulatory Agency (ANVISA)

Andrea Katynski
Health Canada

Shuo Pan
Center for Medical Device Evaluation (CMDE), NMPA
Yue Min
Center for Medical Device Evaluation (CMDE), NMPA

Mariana Isabel Vaz Afonso Pires Madureira
National Security Agency of Medicines and Health Products - Portugal
Matthias Neumann
German Federal Ministry of Health
Nada Alkhayat
European Commission
Stefan De Vos
Belgian National Competent Authority for Medical Devices

Ms Yoko Tateno
Ministry of Health, Labour and Welfare (MHLW)
Yoshifumi Nagai
Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshimasa Yokoyama
Pharmaceuticals and Medical Devices Agency (PMDA)
Yudai Nakazuru
Pharmaceuticals and Medical Devices Agency (PMDA)

Konstantin Ivanov
Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Abdullatif Al Watban
Saudi Food and Drug Authority

Shuling Peng
Health Sciences Authority (HSA)

Jang-yong Choi
Ministry of Food and Drug Safety (MFDS)
Sang-jin Park
Ministry of Food and Drug Safety (MFDS)
Seon-mi Lee
Ministry of Food and Drug Safety (MFDS)
Yunju Lee
Ministry of Food and Drug Safety (MFDS)

Camilla Fleetcroft
Medicines and Healthcare products Regulatory Agency (MHRA)

Erin Keith
Food and Drug Administration (FDA)
Matthew Di Prima
Food and Drug Administration (FDA)