EU Software Classification under MDR/IVDR – New Guidance Document

28 October 2019 |

Article: EU Software Classification under MDR/IVDR – New Guidance Documen

In October 2019 the Medical Device Coordination Group (MDCG) released a new guidance document on Qualification and Classification of Software in the European Regulations 2017/745 – MDR and 2017/746 – IVDR.

Further to the recent webinar by Brandwood CKC on Software as a Medical Device (SaMD) where we discussed medical device software classification, this new guidance by the Europeans confirms the adoption of IMDRF’s (International Medical Device Regulators Forum) guidance approach to software classification (IMDRF/SaMD WG/N12FINAL:2014).

The new guidance covers the definition of medical software and the implementation of new and changed classification rules according to the new medical device & IVD regulations.

Medical Device Software (MDSW)

The guidance defines MDSW as:
“Medical device software is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the medical devices regulation or in vitro diagnostic medical devices regulation”

The definition includes stand-alone software (SaMD), software driving or influencing the use of a device (i.e. used in combination with hardware), and software incorporated into an IVD system. The MDSW is qualified as a Medical Device regardless of its location of use (e.g. phone app, cloud-based etc.). Software that is driving or influencing the use of a medical device is subject to the medical device regulations either as a part/component of a device or as an accessory for a medical device.

Note that not all software used within healthcare will be qualified as a medical device. For example, a patient appointment scheduling system. However, software which is intended to process, analyse, create or modify medical information could be considered as medical device software if the creation or modification of that information has a medical intended purpose.

Essentially, the device’s intended purpose will determine if it qualifies as a medical device.

MDSW Classification under MDR

To determine classification for all medical devices, implementing rules in Annex VIII of Regulation (EU) 2017/745 shall be considered. Specifically Rule 3.3 of Annex VIII clarifies the applicability of software both for those which drive and influence the use of a device, and stand-alone software.
In addition, Recital 5 of the Medical Device Regulation and with the influence by the IMDRF international guidance, Rule 11 was introduced into the MDR. This rule intended to address the risks related to the information provided by an active device, such as MDSW. In particular, the rule describes and categorises the significance of the information provided by active devices to the healthcare decision (patient management) in combination with the healthcare situation (patient condition).

Within the EU Regulations, software (including MDSW) is now clearly defined as an active device. Rules 9, 10, and 11 of Annex VIII MDR 2017/745 should be considered, regardless of the software’s location or the type of interconnection between the software and a (hardware) device. Particular relevance to MDSW is Rule 11 which applies to Software that is used for making decisions with diagnosis or therapeutic purposes or software intended to monitor physiological processes.

Note that other rules (Rule 12, 13, 15 and 22) for devices which may incorporate software, such as those for closed loop systems, devices to administer and/or remove substances, device used for contraception or prevent transmission of STD, and all other active devices, which should be considered and corresponding classifications applied. Where multiple rules apply to the one device then the rule resulting in the highest classification shall be applied.

MDSW Classification under IVDR

For software used within IVD systems all rules in Annex VIII of Regulation (EU) 2017/746 shall be considered. Rules 1.4 and 1.9 need special considerations when determining the applicability to MDSW.

Implementing Rule 1.4 is only applicable for software which drives or influences the use of an in IVD devices. It should be considered at least as means for finding the classification of software in combination with a hardware IVD device. In addition, if the MSW is independent of any other device, it shall be classified in its own right.

In line with the principles of the MDR, implementing Rule 1.9 states that if several classification rules apply to the same device based on the devices’ intended purpose, the rule resulting in higher classification will apply.


It is the Manufacturers’ responsibility to ensure that all regulatory requirements for placing devices on the EU market and conformity assessments have been fulfilled. This begins with classifying the Medical Device or IVD according to the Rules provided in the regulations.

With the increased use of software within or as devices, the classification rules contained within the new EU Regulations (2017/745 – MDR and 2017/746 – IVDR) bring more clarity to address the differences between software incorporated within devices and stand-alone software. Application of the correct rule shall be based on the intended medical purpose, the nature of data provided, the context of use and all supported by an adequate level of clinical evidence.

If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)


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