Diagnostics: Purpose of my service
Attention, the suggested results correspond to the answers checked. They provide an initial insight but they are no substitute for the personalised and in-depth analysis that a legal or regulatory expert can provide
Is your product an accessory to a medical device, does it influence or control the operation of a medical device?
What is considered an accessory for a medical device?
Any item that, while not itself a medical device, is intended by its manufacturer to be used with one or more given medical devices to:
- enable the device(s) to be used in accordance with its/their intended purpose; or
- specifically and directly contribute to the medical function of the medical device(s) as intended.
Software that drives or influences the use of a medical device (hardware) may be described as an accessory for a medical device (hardware).
As a reminder:
Software is said to influence or control a medical device when it does not by itself have a medical purpose but controls or influences the use of a medical device (hardware). This software can, but is not limited to:
- Operate, change the state of, or control the device through an interface (e.g., software, hardware) or through the operator of that device;
- or provide results related to the (hardware) operation of that device.
Regulations:
Practical guide
You don't know how to answer, the keys for choosing
You don't know how to answer, the keys for choosing
To determine if the product you are developing is an accessory to a medical device, it must meet the definition of an accessory and be intended for use with a product that itself qualifies as a medical device.
If your product has multiple components, you may choose to address each component separately from a regulatory perspective, in which case answer the question for each component. You may also choose to treat the individual components as a whole from a regulatory perspective, in which case answer "no" and proceed to the next question to determine if your product is a medical device.
- Example: a mobile application wirelessly connected to a blood pressure monitor to display and record the patient's blood pressure.
Please note that G_NIUS is not designed to help you choose the regulatory strategy to adopt, for that you can call on regulatory specialists.
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