The intended use statement of medical devices is a central aspect in the European regulatory environment. The intended use drives the requirements a device must fulfill. This has already been the case under the medical devices directives.
Under Regulations (EU) 2017/745 and 2017/746 on medical devices or in vitro diagnostic medical devices respectively (MDR and IVDR) with their more specific provisions, this becomes even more important.
AstraCon has developed an online tool to help manufacturers generating an appropriate intended use statement. The tool regards relevant design and performance characteristics and is in line with current regulatory requirements. It can be accessed here.
Should you have any questions or comments, please don’t hesitate to get in touch.