Equivalent Device

The medical devices that has same intended use, same technological characteristics, biological aspects are considered as the equivalent device. As per MDR, the equivalent device selecting to be CE marked. To claim equivalency, it is mandatory to demonstrate the clinical, technical and biological characteristics are same.

The scientific literature selected for the collection and analysis of the clinical data to be the clinical studies done on the equivalent device for the demonstration of the safety and performance of the medical device for the CE marking. According to MDR, it is mandate to hold an agreement with the manufacturer company of the equivalent device to present the evidences for the demonstration of equivalence.

If the devices that do not have CE marking can be used for the equivalency? What is the difference of equivalent device with the similar device?