IMDRF Personalised Medical Devices Working Group

The International Medical Device Regulators Forum (IMDRF) Personalised Medical Devices Working Group develops guidance and recommendations for regulating PMDs.

A harmonised approach for PMD across jurisdictions will benefit all stakeholders.

Membership

Tracey Duffy chairs the IMDRF PMD Working Group. Tracey is the First Assistant Secretary, Medical Devices and Product Quality Division, TGA.

The Working Group includes representatives from:

• Argentina
• Australia
• Brazil
• Canada
• China
• The European Union
• El Salvador
• Japan
• Russia
• Saudi Arabia
• Singapore
• South Korea
• The United Kingdom
• The United States of America.

Initiatives

Documents published

The Working Group has published three technical documents: 

1. Definitions of Personalized Medical Devices

   This includes definitions of custom-made; patient-matched; and adaptable medical devices.

   It introduces 'specified design envelope', a characteristic feature of the patient-matched medical device definition.

2. Personalized Medical Devices - Regulatory Pathways

   Presents concepts and regulatory approaches to Point of Care (POC) manufacturing of medical devices. These apply to a broad range of medical devices and are not restricted to PMDs.

   It introduces the new concept of a Medical Device Production System (MDPS) which may be used in POC manufacturing of medical devices.

   A MDPS is a combination of the various elements of a medical device production process (MDPP) and the resultant medical device that it produces.

   MDPP elements may include:

   • raw materials,
   • software and digital files,
   • main production, and post-processing equipment,
   • operating instructions for end users at a healthcare facility

3. Personalized Medical Devices - Production Verification and Validation

   Provides technical guidance on patient-matched medical devices and MDPSs.

   Regulatory reforms

   In February 2021, the Australian Government introduced regulatory reforms for PMDs. These broadly align with the three IMDRF PMD documents.

   Training materials

   The Working Group is developing guidance and training materials for PMD stakeholders.

   By putting these materials together, there's a consistent understanding of the PMD information. This will reduce regulatory divergence and speed up the adoption.