This short course will cover what a medical device is (and what it is not) and discuss the legislation surrounding the European medical device regulation and why in Europe there is no combination product legislation. Participants will have the opportunity to classify medical devices which is the first step in the conformity assessment pathway leading to the affixing of a CE Mark to a product. This pathway includes a risk assessment, the basics of which will be explained. Mitigation of risk can be achieved in a variety of ways and the course will address some of them, particularly clinical investigations and labelling.
The objective of this short course is to provide a basic understanding of European medical device regulatory requirements and how to ensure compliance with those regulations. Throughout the course there will be short exercises to confirm understanding and opportunities to apply knowledge gained.
An additional registration fee is required for all preconference short courses.
Who should attend?
This short course is designed for individuals with no experience of European medical device legislation who require an introduction to the topic and staff working in the pharmaceutical sector who require a basic understanding of medical devices legislation in Europe.
At the conclusion of this course, participants should be able to:
- Define what a medical device is, and is not;
- Describe the key elements of the European Medical Device Regulation (MDR);
- Classify a medical device;
- Recognize the different steps relating to conformity assessment, risk and data required to gain a CE Mark;
- Interpret the legislation to conduct a clinical investigation and manage a clinical evaluation report.