The information in this document applies to all medical devices, including IVD medical devices. Unless otherwise specified, the principles discussed can be applied to any phase of the product lifecycle (e.g., technical documentation2 review, evaluation of
quality management systems, post-market activities, device changes requiring regulatory review) and are meant to work with a variety of reliance mechanisms (e.g., harmonized decisions, unilateral or multilateral/mutual recognition, work-sharing).
Reliance can also be deployed as a strategic tool during public health emergency contexts, such as pandemics or natural disasters.
As a regulator looking to set up a reliance program, you should note:
• There is information in this document about factors that are beyond your direct control, but is included to give you a broader understanding of factors impacting the design and implementation of a reliance program
• It is not intended to provide an IMDRF-endorsed reliance framework, nor promote one specific reliance framework
• The extent to which an RA relies on a trusted partner’s work can vary. You have flexibility in determining your reliance extent
• You maintain flexibility in how you conduct activities within the reliance scope, including the use of third parties
This document provides advice and information to help you establish a program that
best meets your and your jurisdiction’s needs.