I have a HW medical device that is classified as class I device according to MDD. The device is used for documenting pictures used by a doctor to diagnose disease. A new software feature will be added that will be able to provide diagnosis instead of the doctor.
1. The new feature is not an integral part of the device you would buy, the user will be able to purchase it separately
2. It only works with my HW device, so it is not a stand alone software device
3. The intended use of the feature is different from the intended use of the device
Can I treat this software feature as an accessory to a medical device? I am looking through regulation and it is very unclear when it comes to software.
If it is indeed an accessory, do I need to prepare a separate technical file for the software? or will it be part of my HW device TF?
1. The new feature is not an integral part of the device you would buy, the user will be able to purchase it separately
2. It only works with my HW device, so it is not a stand alone software device
3. The intended use of the feature is different from the intended use of the device
Can I treat this software feature as an accessory to a medical device? I am looking through regulation and it is very unclear when it comes to software.
If it is indeed an accessory, do I need to prepare a separate technical file for the software? or will it be part of my HW device TF?