Clinical investigations with medical devices

As a result of the MDR, the authorisation of medical devices and the conduct of medical device studies is in a transition phase. The length of the transitional periods depends on the risk classes. Clinical testing of medical devices is of paramount importance to ensure the compliance with regulatory requirements and consequently obtain marketing authorisation. It also ensures compliance with the highest standards and safe and effective treatment. 

For each medical device, regardless of the risk class, a clinical evaluation must be conducted and documented. In this context, clinical performance data and clinical safety data relevant to the intended purpose of the device in question have to be appraised and analysed. 
The clinical evaluation is based on clinical data collected from scientific literature (Systematic literature search) and/or clinical investigations/trials.