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

    Current consultations

    Personalized Medical Devices Regulatory Pathways

    Started
    Closing

    Personalized Medical Devices Production Verification and Validation

    Started
    Closing
    personalized-medical-device

    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

    Aya Sakabe
    Ministry of Health, Labour and Welfare (MHLW)
    Mariko Ando
    Ministry of Health, Labour and Welfare (MHLW)
    Yudai Nakazuru
    Pharmaceuticals and Medical Devices Agency (PMDA)
    Yutaku Kaneta
    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)

    Penny Wilson
    Medicines and Healthcare products Regulatory Agency (MHRA)

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