Medical Device Composed of Substances
Medical devices composed of substances or combination of substances intended to be introduced to the human body and are absorbed by or locally dispersed in the human body has to be considered with specific information for the compliance with the MDR requirements. That specific information includes test design, complete test or study protocols, methods of data analysis and data summaries and test conclusions of the below related attributes
• Toxicity- single dose and repeated dose
• Local tolerance
• Possible interaction of those substance in the human body, with other devices, medicinal product to the target population and its associated medical condition.
• Absorption, metabolism, distribution and excretion.
MDR has included a special rule considering the devices composed of substances for the Medical Device classification.
What is the procedure followed for the medical devices composed of the medicinal substance? If the above information is not available how can we justify the safety and performance of the device?