Biological Evaluation

Overview: Biological response to a medical device is wide and complex. The choice of safer constituent material may result in less functional device or vice versa. As the medical devices are known to provide numerous benefits but they all do purchase certain degree of risk. Hence, Biological Evaluation plays important role where the constituent material of device interacts with tissue. The primary aim of EN ISO 10993-1: “Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process”, is to protect the humans from potential biological risks arising from the use of medical devices. However, Medical Device Directive (MDD) and the Medical Device Regulation also provides Essential requirements and General Safety and Performance requirements of Medical device. In order to ensure a high level of protection of health for patience and users regulation (EU) 2017/745 has been implemented.