Medical device manufacturers need testing to medical device’s each functionality on par with increasing complexity in product design, elevated adaptations of wearable medical devices and use of technological advancements to identify unforeseen challenges for the prevention of unacceptable risks to patients. From simple low risk devices such as syringes and disposable gloves to complex high risk devices such as pacemakers and cardiac defibrillators; the medical devices must comply with norms of safety, quality and performance standards. In addition, as per regulatory guidelines, for devices where the patient-contacting portions may contain potentially toxic chemicals, the evaluation of safety will be the major concern. In this line, we provide the toxicological risk assessment of a medical device gathering all possible toxicity data which helps in determining whether a chemical compound present or released from a medical device poses a systemic toxic, genotoxic, carcinogenic, reproductive or developmental toxicological risk.