Carita Group - Better Care

Clinical evidence

Clinical evaluation

MDD 93/42/EEC (Medical Device Directive), amended in 2007/47/EC, requires clinical data and evaluation of that data to ensure the safety of medical devices. Clinical data is collected or generated from the clinical use of the device and by observing the performance and safety of the device. This clinical evaluation needs to prove that the device is safe and performs according to its intended purpose established by the manufacturer. Clinical evaluation is obligatory for every medical device within the European Union.