Clinical Evaluation and CE Marking

Before obtaining CE Marking in the EU, medical device manufacturers must prove to the competent authority that their device meets safety and performance standards and hence, the EU MDR requires the clinical evaluation of their device. Clinical evaluation is a required for all the medical devices regardless of the classification of device.


According to EU MDR – “Clinical Evaluation means a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a medical device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer”.

Is the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements?