The Medical Device Industry is currently transitioning from the Medical Device Directive (MDD) 93/42/EEC to the Medical Device Regulation (MDR) 2017/745. As an industry we need to progress through this transition period in order to keep our products on the European Market and retain our CE mark. It is important therefore that we understand the MDR requirements and the key changes this entails for our products so that we can plan for this change.
This course will look at steps involved in the CE marking process through the MDR (what remains the same, what has changed) as well as other key changes that are required. This course will also link the ISO 13485:2016 quality management system (QMS) requirements to the MDR QMS requirements but emphasizing the importance of the MDR as a legal requirement.