Medical Device Software and Mobile Apps
The current position is clear when it comes to software which is part of a medical device, either to control its actions or monitor it when used. This is treated as part of the device for regulatory purposes and such devices can be “active” or not as defined in the Medical Device Directive, MDD, 93/42/EEC, classification criteria. Active devices work by using a source of energy other than directly generated by the human body or gravity. Active Implantable Devices may also contain software but are regulated by the earlier Active Implantable Medical Device Directive, AIMMD, 90/395/EEC.
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