Clinical data for MDR/IVDR make it easy with real world
We all know that EU MDR and IVDR are clinical data hungry. When the assessment shows that you need additional clinical data and while you spend time and money to collect that, with little more planning, you can increase the mileage drastically. Thinking beyond CE mark goal is important and following some of the methods discussed in this article, you will realize that it can be done cost-effectively. RWD/RWE offer bigger opportunities to device manufacturers not only to gather clinical evidence on their exiting indications but also to fulfill the post marketing obligations on the device.
Real World Data and Evidence (RWD/RWE) provide real picture of how the approved or marketed product is used by HCPs and their patients. RWD offers great potential for filling these gaps in the knowledge and help to get a better understanding of safety and performance with respect to intended use and indication of the device. Apart from this, RWD/RWE also help to get evidence related to expanded access where the device might be used of label but is being used as it shows better effectiveness in other condition. This way real word data can be used for an RWE-based approval of a new indication of the product. This area is becoming increasingly important and necessary for the device companies for their product development and commercialization including reimbursements as they are entering into EU MDR era which will be in force in May 2020.