Reasons to attend
The Medical Device Regulation MDR 2017/745 is into effect from May 2021 in Europe. In this course, you will learn how the MDR has been translated in Belgium and how clinical investigations with medical devices are carried out there.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
- Half a Day face-to-face training: 9:00 to 12:30
In this half-day training, we will zoom in on processes and legislative guidance documents implementing the MDR 2017/745 in Belgium. This course is complementary to our MDR Training.
The course consists of 3 parts, covering translational aspects, submissions, and reporting of clinical investigations in Belgium:
You will learn how submission for approval of clinical investigations works and finally, you will learn how reporting of your investigation (safety reports and study reports) works in Belgium.