Intended purpose of medical devices and IVD devices
In the Medical Devices Regulation, ‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation or in the performance evaluation of an IVD device.
Classification of medical devices
Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII of Regulation (EU) 2017/745.
Classification of in vitro diagnostic (IVD) medical devices
IVD devices are classified on the basis of how essential the proper functioning of the device is in diagnosing an illness or state of health, or what kind of health risk to the individual or public health the insufficient functioning of the device may pose. The risk classification of the device takes into account the intended user group of the device and the scientific, technical or medical expertise required of the user (devices for lay persons, devices for laboratory professionals and near-patient testing devices for other healthcare professionals).
For conformity assessment, the manufacturer must determine the category to which the device belongs.
According to the old IVD Directive (98/79/EC), IVD products are classified as follows:
- List A devices of Annex II to the IVD Directive (see p. 23 of the IVD Directive for details)
- List B devices of Annex II to the IVD Directive (see p. 23 of the IVD Directive for details)
- Devices for self-testing (Note: devices for self-testing may also be List A or List B devices at the same time)
- other IVD devices (“general IVD devices”).
A device for self-testing means an IVD device intended by the manufacturer for use by a non-healthcare professional (also known as at-home tests for lay persons).
The IVD Directive will be applied until 26 May 2022, after which date the device must meet the requirements of the IVD Regulation. After 26 May 2022, it will be possible, under certain conditions, to apply the transitional provisions of the IVD Regulation to List A and List B devices and devices for self-testing placed on the market under the Directive.
The In Vitro Diagnostic Medical Devices Regulation (IVDR, (EU) 2017/746) introduces a new classification system that more clearly reflects the risks of the product concerned. IVD devices are classified into classes A, B, C and D based on their intended use in accordance with the rules set out in Annex VIII to the Regulation.
Classification of software
The classification of software is based on the same rules as the classification of other medical devices and IVD devices. However, the specific questions concerning the classification of software have been addressed in a number of guidance documents focusing specifically on the classification of software. See the Software page for further information.
Guidance for classification
MDCG endorsed documents and other guidance (European commission)
MDCG 2020-16, Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (European commission)
MDCG 2019-11, Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR (European commission)
Is your software a Medical Device? (European commission)