The IMDRF Personalized Medical Devices (PMD) Working Group has today updated the final guidance document on ‘Personalized Medical Devices – Regulatory Pathways’. This Edition 2 builds on the previous document released in 2020.

This document applies to all personalized medical devices (PMDs) and is intended to identify and describe different regulatory pathways and their requirements for the different categories of personalized devices that are defined in the IMDRF document N49, Definitions for Personalized Medical Devices.

Note: Excluded from the scope are in vitro diagnostic medical devices.