Diagnostics: Is my solution a DM?

Please note: the results shown correspond to the answers you ticked. They provide an initial overview, but in no way replace the personalized, in-depth analysis that can be provided by a legal or regulatory expert

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Is your product an accessory to a medical device (MD), or does it influence or control the operation of an MD?

YES

NO

What are DM accessories?

Any article which, without itself being a medical device, is intended by its manufacturer to be used with one or more given medical devices to:

  • permit use of the latter in accordance with its or their intended purpose; or
  • to contribute specifically and directly to the medical function of the medical device(s) according to its/their intended purpose.

Software that controls or influences the use of a medical device (hardware) can be qualified as an accessory for a medical device (hardware).

For the record:

Software is said to influence or control a medical device when it does not in itself have a medical purpose but controls or influences the use of a medical device (hardware). Such software may, but is not limited to:

  • operate, modify the state of or control the device via an interface (e.g. software, hardware) or via the operator of that device;
  • or provide results related to the (hardware) operation of this device.

Regulations:

Consult the European regulation

Practical guide

You don't know how to answer, the keys to choosing

You don't know how to answer: the keys to choosing

To determine whether the product you're 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 is made up of several components, you may choose to treat each component separately from a regulatory point of view, in which case answer the question for each component. Alternatively, you may choose to treat these different elements as a whole from a regulatory point of view, in which case answer "no" and go on to the next question to find out whether your whole constitutes a medical device.

  • Example: a mobile app wirelessly linked to a blood pressure monitor to display and record the patient's blood pressure.

Please note, G_NIUS is not designed to help you choose which regulatory strategy to adopt, for this you can call on regulatory specialists.

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