1. Introduction



In the last decades, the evolution of new technologies contributed to the development and implementation of the new regulatory framework on which MDR and IVDR are grounded. Legislators worked to create a regulatory environment that would respond to past problems (e.g., the introduction of nanotechnology in MDs, exponential growth of software as a Medical Device) and the challenges of the future (e.g., the incorporation of Artificial Intelligence, increasing complexity of combined products), ensuring the performance and safety of Medical Devices that incorporate these novelties without compromising the public access to new and emerging technologies. Knowing how some of these challenges are being addressed by the regulator is key to understanding how the boundaries between all these technologies are being defined.

We strongly recommend starting with the Regulatory sections of Course 1 (Introduction to Medical Devices and their regulatory framework) before doing this course and lesson.