Medical Device Clinical Investigations
Medical device clinical trials are completely new regulated under the EU MDR. Manufacturers are faced with new challenges.
Manufacturers of medical devices must carry out a clinical evaluation of their products in order to be allowed to market them in Europe. To do this, the manufacturer must use clinical data to check whether the medical device is safe and efficient.
Manufacturers must do a clinical evaluation of a medical device before they can market it in Europe. Find out what you need to keep in mind.