Medical Device Classification?
Posted: Fri May 10, 2024 12:58 am
Hello Everyone,
We are trying to obtain ethics to use OpenCap with NHS patients here in the UK for a research study to determine how feedback of their walking gait within a session improves their rehabilitation. To do this we have to apply for a pretty rigorous ethics through the UK NHS system. The university ethics department is concerned about whether we need to apply for ethics that classifies our study as a clinical investigation of a medical device, or, conducting a clinical trial of investigational medicinal products. As far as I am aware, OpenCap software does not have any license for medical use? We do not think that OpenCap would need this kind of medical mark (CE mark) to be used in a research study?
Has anyone else come across similar issues and have any advice for how to get around this?
Much appreciated,
Logan Wade
We are trying to obtain ethics to use OpenCap with NHS patients here in the UK for a research study to determine how feedback of their walking gait within a session improves their rehabilitation. To do this we have to apply for a pretty rigorous ethics through the UK NHS system. The university ethics department is concerned about whether we need to apply for ethics that classifies our study as a clinical investigation of a medical device, or, conducting a clinical trial of investigational medicinal products. As far as I am aware, OpenCap software does not have any license for medical use? We do not think that OpenCap would need this kind of medical mark (CE mark) to be used in a research study?
Has anyone else come across similar issues and have any advice for how to get around this?
Much appreciated,
Logan Wade