Guiding principles have been developed for use by the IMDRF to advance health equity discussions for underrepresented populations in the development, evaluation and regulation of medical devices. This document is intended to assist IMDRF working groups in considering health equity principles, where relevant, in the development of IMDRF technical documents. These principles should be considered throughout the total product lifecycle.
Each working group will determine how best to use this document in their discussions and deliverables.
The document can be downloaded in our library