The Medical Devices Introductory Course 2020

Medical Technology Overview

The medical device industry is … ● diverse ● fragmented ● rapidly growing ● mainly SME ’ s, often with only limited resources (blended RA/QA roles?) ● expanding into novel, rapidly evolving technological areas

Typically medical devices have a short innovation cycle (average 12-24 months) and a short or continuous incremental life cycle development phase (seen as closer to I.T. rather than the pharmaceutical industry, with its extensive development cycle times and investment recovery period) These elements are reflected in the Regulatory legislation applied to devices in the EU ...

So, how are medical devices regulated? Because of the breadth of technologies involved (and likelihood of challenging new technologies, some not yet conceived) ...

Regulatory requirements and controls apply a general risk- based approach that needs to be adaptive to accommodate (and future proof for) this

High

High

Level of Regulatory Control

Product Risk Class

Medium

Medium

Low

Low

The Organisation for Professionals in Regulatory Affairs