The purpose of this IMDRF guidance is to recommend a harmonized 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 identified category of personalized medical device. The adoption of consistent, harmonized requirements for such medical devices will underpin a harmonized regulatory approach for controls on these types of medical devices and offer significant benefits to the manufacturer, user, patient, and to Regulatory Authorities. Eliminating differences between jurisdictions supports global
convergence, reduces the cost of gaining regulatory compliance and allows patients and healthcare professionals earlier access to new treatments and technologies.
This document includes an overview of some of the considerations and concepts that may be relevant in developing a harmonised assessment approach in future.
This document applies to all personalized medical devices, 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.