Is Clinical evaluation necessary for Class I and Ir for a manufacturer who is producing pre established devices? Are both processes Clinical evaluation and clinical investigation be conducted or any one?
Clinical evaluation is required for all medical devices that are to be placed on the EU market. The need for clinical investigation depends on the device and the classification.
Very helpful. Thank you!
which class of device mandates for clinical investigation
Thanks, it's very informative
Is Clinical evaluation necessary for Class I and Ir for a manufacturer who is producing pre established devices?
Are both processes Clinical evaluation and clinical investigation be conducted or any one?
Clinical evaluation is required for all medical devices that are to be placed on the EU market. The need for clinical investigation depends on the device and the classification.