New regulations have introduced more extensive and more detailed requirements on medical devices. Medical device manufacturers are now facing even more rigid requirements on clinical evidence, and they need to provide detailed technical documentation of clinical data.
To be able to continue placing products on the market, it will be necessary to review existing clinical evaluations for all products to investigate whether sufficient clinical data is available. For new products, a clinical evaluation should be performed in an early phase of product development to identify the potential need for a clinical investigation.
When a clinical investigation is set up, proficient design, performance and documentation are of the utmost importance.
This paper will provide insights about how medical device companies can prepare a strategy to fulfill the requirements on clinical data to meet the Medical Device Regulation (MDR), 2017/745.