Module 19 2021

01/06/2021

Warning!!!!

This presentation does not cover all regulatory requirements by any means and should be used as a guide only. The points presented are a personal view and do not represent those of any company or organisation.

3

The global picture

Of those that regulate medical devices, only approx 50% have a definition of IVDs regulations! Global Atlas of medical devices WHO medical devices technical series ISBN: 978-92-4-151231-2

4

2