Classifying Software Under MDR, IVDR: New Guidance From MDCG

Regulatory NewsRegulatory News | 11 October 2019 |  By 

The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to help medical software manufacturers understand the criteria for the qualification of software under the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

The guidance discusses certain types of software that would be classified under MDR or IVDR, such as software that can directly control a (hardware) medical device (e.g. radiotherapy treatment software), can provide immediate decision-triggering information (e.g. blood glucose meter software) or provide support for health professionals (e.g. electrocardiogram interpretation software).

For instance, medical device software (MDSW) may be independent and able to receive measurements. The guidance uses the example of software that can use transrectal ultrasound findings, age and in vitro diagnostic instruments to calculate a patient’s risk of developing prostate cancer. Or the software may “drive or influence” a medical device and the guidance points to software connected to a closed-loop insulin delivery system as an example.

“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,” the guidance notes. Software also may be qualified as MDSW “regardless of its location (e.g. operating in the cloud, on a computer, on a mobile phone, or as an additional functionality on a hardware medical device)."

The 28-page guidance also features a decision tree with five steps for the qualification of MDSW and another tree with three decisions for the qualification of MDSW as either a medical device or an IVD.

Examples for the classification of MDSW under the IVDR include:
  • "Software intended to be installed on a fully automated enzyme-linked immunosorbent assay (ELISA) analyser, and intended to determine the Human HbA1c concentration in serum from the results obtained with a Human HbA1c ELISA, intended to screen for and diagnose diabetes and monitor diabetic patients, should be in class C per Rule 3(k).
  • Software within a PAP stain automated cervical cytology screening system, intended to classify the PAP cervical smear as either normal or suspicious, should be in class C per Rule 3(h).
  • Software for the interpretation of automated readings of line immunoassay for the confirmation and determination of antibodies to HIV-1, HIV-1 group O and HIV-2 in human serum and plasma, should be in class D per Rule 1.
  • Software that uses maternal parameters such as age, concentration of serum markers and information obtained through foetal ultrasound examination for evaluating the risk of trisomy 21, should be in class C per Rule 3(l)."
The section of the guidance on implementing rules further notes that MDSW “that both achieves its own intended purpose and also drives or influences the use of a (hardware) device for a medical purpose is classified on its own, based on the intended purpose achieved. In such a case, however, the risk class shall not be lower than the risk class of the hardware medical device.”

For an example, the guidance points to melanoma image analysis software intended to be used with a near-infrared laser light scanner, which is considered class IIa.

“The software ‘drives or influences the use of’ the near-infrared laser light scanner as it is intended to take control of the scanner by letting it execute proprietary multi-exposure programs for the detection of melanoma. As such, implementing rule 3.3 applies. However, Rule 11 would also apply based on the intended medical purpose of the software e.g. cancer diagnosis. The MDSW would be classified as class III based on Rule 11 (see section Classification Rules) and per implementing rule 3.5 of Annex VIII,” the guidance says.

In line with part of MDR and international guidance from the International Medical Device Regulators Forum, the MDCG further explains Rule 11 and how it is intended to address the risks related to the information provided by an active device and that it describes and categorizes the “significance of the information provided by the active device to the healthcare decision (patient management) in combination with the healthcare situation (patient condition).”

Other classification and implementing rules related to IVDR are also included in the guidance.

Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR


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