Active implantable Medical Device’ are those devices which require source of Electrical Energy or any source of power other than that generated by the human body or by gravity. Due to increasing investments in the innovations & R&D sector Medical Industry are giving more focus to ‘Active implantable Medical Devices’ to develop compact design, User-friendly & efficient medical devices without compromising the safety of the patient. Active Medical Device manufacturers must ensure that their device should meet the EU-MDR 2017/745 requirements before placing the device in the European market.
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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