Active implantable Medical devices:
Active Medical Devices are classified as per ‘Rule 9 – Rule 13’ according to EU-MDR 2017/745 Annexure VIII: Classification Rules. New Rule has been introduced under the Active Medical Devices which is related to the ‘Software based Medical devices’. This includes Software itself a medical device and the medical device that incorporates the software.
EN 60601 series of standards is widely accepted for Active Medical Devices and compliance with these standards is one of the essential requirement for selling the device in the European market. So the Additional testing need to be performed on the Active Medical devices to address the safety and effectiveness.
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