In a former video, we talked about the importance of quality management in a clinical investigation. In today’s video I will briefly answer the following question:
“Why is the selection of investigators so important for the success of your clinical investigation and market access of your medical device?
As mentioned in the video of the key changes of the MDR on clinical investigations, more clinical data is needed to obtain a CE mark under the MDR.
Real-world clinical data can be easily gathered by post-market, observational studies, like registry studies. These studies are often initiated and conducted by investigators in so-called Investigator Initiated Studies, in which the investigator also assumes the Sponsor role.
The quality of the clinical data is of great importance for manufacturers to comply with the MDR requirements, as described in the article on harmonized standards. By following the ISO14155, conformity with the MDR requirements is met.
During the selection process, the qualifications of the investigator and the site should proof profound knowledge of ISO14155 as well as implementation of quality management principles to generate good qualitative clinical data.
