Classification of medical device software in the European Union

Medical device software (MDSW) is a rapidly growing sector, and as such, the regulations surrounding its development, testing, and marketing are constantly evolving to capture these new technologies. In the EU, MDSW is regulated by Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR).

Other than the above-mentioned regulations, several documents support stakeholders in the compliance process, such as certain documents published by the Medical Device Coordination Group (MDCG), in particular MDCG 2019-11, and the International Medical Device Regulators Forum (IMDRF) on software as a medical device (SaMD) as well as international standards (IEC 62304).

What is medical device software?

MDCG 2019-11 defines MDSW as “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 MDR or IVDR, regardless of whether the software is independent or driving or influencing the use of a device”. According to the guidance, a MDSW to be qualified as such needs to either:

  • meet the definition of “medical device” set out in Art. 2 MDR, or
  • meet the definition of “MDR Annex XVI device”

Alternatively, if the device per se cannot be considered a medical device as per the two definitions above, it should either:

  • fulfil the definition of “accessory” to a medical device or to an in-vitro diagnostic medical device, or
  • be considered a “software driving or influencing the use of a (hardware) medical device”. According to the guidance, “this software can, but is not limited to: a) operate, modify the state of, or control the device either through an interface (e.g., software, hardware) or via the operator of this device b) or supply output related to the (hardware) functioning of that device”.

Should the above instances not apply, the manufacturer has to consider whether the software is performing an action on data other than storage, archival, communication, or simple search and whether the action is for the benefit of individual patients, while also meeting the definition of MDSW explained above. Should it be the case, the device is covered by the medical device regulations in the EU: what is left to be determined is whether MDR or IVDR applies and which risk class it belongs to in order to allow the manufacturer to follow the appropriate conformity assessment procedure.

MDCG 2019-11 and the MDR- or IVDR-specific classification guidance documents (MDCG 2021-24 for MDR; MDCG 2020-16 for IVDR) represent valid navigation tools for manufacturers to classify their devices under both regulations.

MDSW and the IVDR

For the MDSW to fall within the scope of the IVDR the device should:

  • Provide information within the scope of the IVD definition and
  • Provide information based on data obtained by IVD medical devices only or its intended purpose is substantially driven by IVD data sources

As per IVDR Annex VIII, paragraph 1.4, independent software shall be classified in its own right while software driving a device or influencing its use, shall fall within the same class as the device. Therefore, all seven classification rules are potentially applicable, and adequate justification shall be provided in the technical file.

Also in this case, the rule resulting in the higher classification shall apply if several classification rules apply simultaneously according to the intended use of the device. MDCG 2019-11 and MDCG 2020-16 provide non-exhaustive examples of IVD devices classification by rule.

MDSW and the MDR

Should the MDSW not provide information within the scope of the IVD definition, the MDSW shall fall under MDR.

As per Annex VIII MDR, Rules 9 to 13 concern active devices, and as software is considered to be an active device, MDSW should be considered along with special rule 15 concerning devices used for contraception or prevention of the transmission of sexually transmitted diseases and rule 22 for active therapeutic devices with an integrated or incorporated diagnostic function. Manufacturers should always keep in mind that the rule or sub-rule resulting in the strictest classification applies. Appropriate justification for the classification shall be provided in the technical file.

Rule 11 – introduced by the MDR – represents an innovation in the EU medical devices framework. Following its interpretation, MDSW can be classified as following:

  • Software intended to provide information to take decisions with diagnostic or therapeutic purposes are classified as Class IIa , IIb or III depending on inherent risk;
  • Software intended to monitor physiological processes can be Class IIa or IIb depending on inherent risk;
  • Software that is not captured by the previous two sub-rules (or by other stricter rules within MDR) is classified as Class I.

While in theory, the third sub-rule acts as a residual rule, in practice, MDSW by definition will most likely fall under the first two sub-rules or will hardly satisfy the condition that it must perform “an action on data different from storage, archival, communication or simple search”. Consequently, very few devices will fall under Class I, and thus, MDSW will require the intervention of a notified body in most cases.

As of May 2023, MDCG 2019-11 provides one example of Class I medical device software: MDSW “intended to support conception by calculating the user’s fertility status based on a validated statistical algorithm”, or fertility apps. It must be pointed out that however, an app whose intended purpose is contraception would be classified as Class IIb according to Rule 15 (stricter rule). Moreover, software driving a device or influencing its use, shall fall under the same class of the device in question.

Following this example, other contributions to this research question suggested that software whose intended user is the patient rather than the healthcare professional may fall under Class I. Johner (2022) mentions that software that assists patients in training to compensate for a specific medical condition (e.g. apps for pelvic floor training against erectile disfunction, software for developing certain health habits to overcome addictions, etc.) could be considered as Class I medical device software. In a similar fashion, Bartolozzi (2019) considers a medication module that gives patients information for appropriate medication to treat, alleviate, compensate for an injury or handicap also a Class I, as it not used for decision making with therapeutic purposes or direct diagnosis.

The impact of MDR and IVDR on Medical Device Software

The Medical Device Regulations bring progress in the incorporation of new technologies that were previously subject to residual classification rules or rules designated for equivalent hardware active devices. Compared to Directive 93/42/EEC, the definition of medical device as per MDR Art. 2 now explicitly includes the wording ‘software’ as well.

As far as IVDR is concerned, the new risk-based classification system into Class A, B, C and D has urged not only software but also many conventional, hardware IVDs to undergo an up-classification. Though the classification system under MDR has not been radically changed, by adding a dedicated classification rule in MDR (Rule 11), MDSW manufacturers need to carefully reassess the classification in the following cases:

  • When transiting from MDD to MDR
  • If the software did not fall under the scope of MDD and if it is now captured by the new Regulation.

As a result, in most cases under both Regulations MDSW manufacturers will have to seek a notified body to achieve regulatory compliance in the EU.

Tancredi Vergani

Regulatory Affairs Department


Are you a medical device software manufacturer based outside of the EU? Obelis can assist you with the MDR and/or IVDR compliance process and become your European Authorised Representative.


Bartolozzi, A. (2019). MDR and Medical Device Software. Rule 11 vs Rule 10. Retrieved on 09 May.

Chhaya, V. and Khambholja, K. (2021). The SaMD regulatory landscape in the US and Europe. Retrieved on 08 May 2023.

European Commission (2021). Is your software a medical device? Retrieved on 08 May 2023.

International Medical Device Regulators Forum (2013). Technical Document IMDRF/SaMD WG/N10. Software as a Medical Device (SaMD): Key Definitions. Retrieved on 17 May 2023.

Johner, C. Prof. Dr. (2022). Klasse-I-Software. Retrieved on 08 May 2023.

Hovestadt, L. (2021). Medical device software under the EU MDR. Retrieved on 08 May 2023.

Medical Device Coordination Group (2019). MDCG 2019-11. Guidance on Qualification and classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. Retrieved on 08 May 2023.

Medical Device Coordination Group (2021). MDCG 2021-24. Guidance on classification of medical devices. Retrieved on 08 May 2023.

Medical Device Coordination Group (2023). MDCG 2020-16 Rev. 2. Guidance on Classification Rules or in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. Retrieved on 08 May.


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