The International Medical Device Regulators Forum (IMDRF) working group on Personalized Medical Devices seeks to develop guidance that establishes definitions and regulatory pathways for Regulatory Authorities to consider in the regulation of medical devices that are intended for individual patients. The goal is to promote global harmonisation in the terminology and premarket requirements for such devices. The working group's chair is Dr Elizabeth McGrath (TGA).
The purpose of this draft IMDRF guidance is to recommend a harmonised approach for the application of existing regulatory pathways to medical devices that are intended for a particular individual, and to identify special considerations for the regulation of each category of personalized medical device.
The IMDRF working group is seeking comments from interested parties on a proposed guidance document:
