Point-of-care Manufacturing of Medical Devices Steering Committee, Meeting statement, Meeting 1, 17 November 2023

The Point-of-care (POC) Manufacturing of Medical Devices Steering Committee met for the first time on 17 November 2023 via videoconference.

Key discussion points included: 

• The introduction of the personalised medical devices framework.
• The content and outcomes from the National Symposium attended by state/territory government health departments and federal regulators.
• The commencement of the point-of-care manufacturing work.
• The scope and role of the Steering Committee including the need for the Committee to focus on patient safety and delivering appropriate regulatory outcomes absent of bias or influence from any individual or group within each sector.
• The need for a robust Terms of Reference for the Steering Committee outlining the responsibility members have for:
  • defining and documenting the issues including identifying challenging gaps
  • providing advice on potential options for implementing solutions relevant to their scope of control
  • progressing outcomes from the POC manufacturing work within the structures and governance of their own agencies and organisations
  • delivering outcomes that focus on patient safety and align with best practice regulation including addressing risks appropriately without introducing unnecessary burden
• The proposed membership of the sector-specific Working Groups.
• The need for a well-defined plan of forward work for the Steering Committee and the Working Groups.

More information

Meeting statements and information on the Point-of-care Manufacturing of Medical Devices Steering Committee, visit POC Manufacturing of Medical Devices Steering Committee and Working Groups.