Clinical evaluation is mandatory for demonstrating conformity with Essential Requirements. Guide applies to medical devices regulated by directives 90/385/EEC and 93/42/EEC. Does not cover in vitro diagnostic devices. Clinical evaluation should be flexible and appropriate to device nature
EHS is claimed sensitivity to electromagnetic fields causing various non-specific symptoms. Symptoms include headaches, fatigue, stress, skin problems, and muscle aches. No specific symptoms exist, and prevalence varies geographically and culturally
Differential diagnosis helps distinguish between similar clinical features of different diseases. Used by clinicians to diagnose specific conditions or consider life-threatening ones. Can be applied in psychiatry for patients with similar symptoms
URR measures dialysis quality by assessing waste product elimination from blood. URR should be measured monthly or every 12th dialysis session. Dialysis is considered adequate if URR is ≥65%
Clinical evaluation is mandatory for demonstrating conformity with Essential Requirements. Guide applies to medical devices regulated by directives 90/385/EEC and 93/42/EEC. Does not cover in vitro diagnostic devices. Clinical evaluation should be flexible and appropriate to device nature
Performance status measures daily activities and treatment tolerance in cancer patients. Helps estimate prognosis and evaluate treatment response. Essential for clinical trials and quality of life management