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IMDRF consultation: Personalised Medical Devices - Regulatory Pathways

24 June 2019

This consultation closed on 24 July 2019.

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:

The TGA (together with all other working group members) invite interested parties to comment on the document.

Deadline for submissions

Interested parties should make submissions, following the consultation submission process detailed on the IMDRF web page, by Wednesday 24 July 2019.

Do not send your responses to the TGA.

Instructions on making comments and any enquiries are included on the IMDRF website linked above.

Further information about IMDRF consultations

Further details about current (and closed) consultations, including how to make submissions, are available on the Consultations page of the IMDRF website.