Go to the next question to determine if it is regulated by the MDR or IVDR.

Medical device

... it is a non-reusable device for administering a medicine.

The device and the medicinal product are an integral product which is intended to be used in combination only and cannot be reused.

The integral product of the device and the medicinal product is NOT considered a medical device and is not covered by the MDR, but by Directive 2001/83 / EC or Regulation (EC) No 726/2004.

Please note: as far as safety and performance of the device are concerned, the general safety and performance requirements of Annex I of the MDR apply.

To classification quick scan

Not a medical device, but ...

It is a medical device which is regulated by the MDR.

Use the quick scan classification of the MDR to determine the device's risk class.

The software is considered to be part of a medical device. The software will certified together with the tool.

Do the quick scan Medical device for the device itself to determine if it falls under the MDR or IVDR.

Use the quick scan classification to determine the device's risk class.

Part of a medical device

... it does concern an accessory for a medical device, which also falls under the MDR.

An accessory for a medical device is not a medical device in itself, but is regarded by the MDR as a device that must meet all the requirements of the MDR.

If the software is intended to control or influence a (hardware) medical device or to display the output of a (hardware) medical device, the software has the same classification as the (hardware) medical device.

Use the quickscan classification to determine the device's risk class.

Not a medical device of its own, but...

...it does concern an accessory for a medical device, which also falls under the MDR

An accessory for a medical device is not a medical device in itself but is regarded by the MDR as a device that must meet all the requirements of the MDR.

No medical device

It is an in-vitro diagnostic medical device and regulated by the IVDR.

Note: In some cases, the MDR may also apply.

Example: If taking a blood sample is part of the device, the MDR is also valid.

Medical device for in-vitro diagnostics

...it does concern an accessory for a medical device, which also falls under the IVDR

An accessory for a medical device is not a medical device in itself but is regarded by the IVDR as a device that must meet all the requirements of the IVDR.

Directly to the quick scan

Is your device or software a medical device?

Is the tool intended to enable the medical use of another medical device or to specifically and directly assist the medical functionality of another medical device?

Is the device intended to be used for human beings?

Does the software perform a task or action on data different from storage, archive, communication, or a simple search?

Is het hulpmiddel bestemd voor in-vitrodiagnostisch onderzoek van specimens afkomstig van het menselijk lichaam, inclusief bloed- en weefseldonaties?

Is the software intended to be used together with another (hardware) medical device to enable the medical use of this other device?

Is it used for cleaning, disinfecting or sterilisation of medical devices?

examination of specimens, including blood and tissue donations, derived from the human body?

Is it used to investigate, replace or modify the anatomy or a physiological/pathological process or state?

Is it used for one or more of the following purposes?

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease

diagnosis, monitoring, treatment, alleviation of or compensation for, an injury or disability

Is the tool a device intended for the administration of a medicinal product and do the device and medicinal product form a single integral product which is not reusable?

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease

diagnosis, monitoring, treatment, relief or compensation, for an injury or disability

 examination of samples, including blood and tissue donations, from the human body or in relation to specimen receptacle?

Is the software used for conception control?

Is it used for the control or support of conception?

Is the software used for one or more of the following purposes? - diagnosis, prevention, monitoring, prediction, prognosis, treatment or allevation of disease - diagnosis, monitoring, treatment, allevation of, or compensation for, an injury or disability

Is the software part of - or installed on - a medical device?