Clinical Data for MDR/IVDR, Make it Easy with Real World approach
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, it also helps to get evidence related to expanded access where device might be used off label but is being used as it shows better effectiveness in other condition. This way real word data can be used for a 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.
Topics covered in this Whitepaper include:
- Understanding Clinical evidence needs
- Regulatory & Clinical Aspects of RWD/RWE