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 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 devices and offer significant benefits to the manufacturer, user, patient, and to Regulatory Authorities.
Eliminating differences between jurisdictions supports global convergence, decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments. This document overviews some of the considerations and concepts that may be relevant in developing a harmonised assessment approach in future
PROPOSED DOCUMENT Personalized Medical Devices – Regulatory Pathways
Authoring Group: IMDRF Personalized Medical Devices