The International Medical Device Regulators Forum (IMDRF) has recently issued a final guidance document to outline its expectations around the regulatory landscape for personalized medical devices. This recent guidance document builds on the previous IMDRF document, ‘Definitions for Personalized Medical Devices’...

1. IMDRF’s New Regulatory Landscape for Personalized Medical Devices
By: Nikita Angane
The International Medical Device Regulators Forum (IMDRF) has recently issued a final
guidance document to outline its expectations around the regulatory landscape for personalized
medical devices. This recent guidance document builds on the previous IMDRF document,
‘Definitions for Personalized Medical Devices’.1
According to the guidance document, custom made medical devices that are intended to
treat/diagnose special cases where commercially available products/therapies are inadequate
for meeting the needs of particular individuals must comply with the following requirements:2
 Determine the classification of the device assuming it is not a custom-made product and
consider applying the equivalent regulatory requirements of the jurisdiction it is sold in.
 Conduct Risk analysis
 Appropriate physical testing
 Manufacturing and record-keeping under a Quality Management System
 For high-risk custom-made devices, IMDRF recommends a third-party oversight such as
that of an auditing organization for their QMS
 Registration and notification as per applicable jurisdictional regulatory authorities
 Follow a post-market surveillance, corrective, and adverse event reporting program
For patient-matched medical devices where the devices are designed and produced for an
individual within validated parameters of a specified design, the manufacturer must
demonstrate safety by identifying the maximum performance limits and limiting configurations
related to manufacturing variables.2
In addition to all of this, manufacturers of personalized medical devices must keep records of
the documented requests and specific design characteristics from the health care professionals.
For implantable medical devices, IMDRF recommends a period of at least 15 years for housing
such records and for all other devices at least 5 years.2
Need help building a QMS? Call us today at 248-987-4497 or email us at
info@emmainternational.com.
1 BSI (July 2020) New guidanceon regulatory pathways for personalized medical devices retrieved on 07/13/2020
from https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/new-guidance-on-regulatory-pathways-
for-personalized-medical-devices/?utm_source=pardot&utm_medium=email&utm_campaign=SM-SUB-LG-CN-
meddev_blog-2001-2012
2 IMDRF (March 2020) Personalized Medical Devices- Regulatory Pathways retrieved on 07/13/2020 from
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-pmd-rp-n58.pdf