Medical device CE marking

IMDRF: Personalized Medical Devices – Regulatory Pathways


The IMDRF published the second edition of their guidance document concerning Personalized Medical Devices.

The primary 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 (PMD). 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 (RAs). 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 harmonized assessment approach in future.

The guidance can be downloaded in our library