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Personalized Medical Devices

The purpose of this Work item is 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 harmonization in the terminology and premarket requirements for such devices.

The working group will develop an IMDRF Technical Document that will provide recommendations to support a harmonized approach to defining different categories of medical devices that are intended for individual patients.

  • Definitions for Personalized (Patient-Specific, Customized and Custom-made) Medical Devices

Working Group Chair: Dr Elizabeth McGrath, Australia

Working Group Membership: Regulator membership (membership to be advised)