Diagnostics: Purpose of my service

Please note that the results correspond to the answers you have ticked. They provide an insight but cannot replace 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?

YES

NO

What is an accessory to a medical device?

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

  • Enable the medical device(s) to be used in accordance with its intended purpose ;
  • Or contribute directly and explicitly to the indended medical function of the medical device(s).

Additionally, it is worth noting that a software program designed to control or impact the use of a hardware medical device may also be classified as an accessory to a medical device.

As a reminder:

A software is said to control or affect a medical device when it has no medical purpose of its own. Such software may, but not limited to:

  • Operate, change the state of, or control the device through an interface (e.g., software, hardware) or through a human operator ;
  • Provide results related to the operation of the hardware of that device.

Regulations:

Consult the European 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.

You would like to receive advice on the classification of your solution

Please visit :

  • The "Guichet orientation et innovation" page of the ANSM (National Agency for Medicines and Health Products Safety), which enables developers of innovative healthcare products to request scientific, technical, legal, and/or regulatory support from the ANSM teams.

  • The Software page of the ANSM, which offers answers to your questions if you intend to market healthcare software or a mobile health application.

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