Is the device a medical device?

​The requirements in the new regulations MDR and IVDR apply to medical devices and in-vitro diagnostic medical devices with intended medical use. MDR also sets requirements for some products without an intended medical use but which have the same risk as medical devices, such as non-prescription contact lenses. In order to know which requirements the device must fulfil, the manufacturer must first determine whether the device is a medical device or an in-vitro diagnostic medical device.  

For additional information, see classification​ (in Norwegian).