MDCG defines an active medical device as
“any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of, or converting that energy.”
The term Software as a medical device is defined by the MDCG as a set of instructions that processes input data (data provided through the use of a human data-input device) and creates output data (data produced by software) and are therefore deemed to be an active device as per the MDR guidelines. Medical device software is intended to drive/influence the use of a (hardware) medical device, used alone, or in combination, for a purpose as specified in the guidance document.
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The guideline lays out qualification criteria to clarify what type of software may subject to the regulations. The guideline states that the “Software must have a medical purpose on its own to be qualified as an MDSW.”
Firstly, the manufacturer’s product must fulfill the definition of a “medical device”, “software”, or in vitro diagnostic medical device according to Article 2(1) of Regulation (EU) 2017/745 – MDR and/or Article 2(2) of Regulation (EU) 2017/746 – IVDR. The intended purpose of the software described by the manufacturer is relevant to qualifying the software as a device and further addressing its classification.
Implementation rules 3.3 and 3.5 described in the Regulation (EU) 2017/745 – MDR or Regulation (EU) 2017/746 – IVDR also respectively apply when the software is intended as an accessory to a medical device and does not meet the definition of a medical device or an in vitro diagnostic medical device.
The qualifying factors of software as a medical device is independent of the risk of harm to users (both patients and professionals) within a healthcare setup.
- Software that directly controls a medical device (hardware), providing immediate decision-triggering information intended to be used by healthcare professionals or patients (e.g. blood glucose meter software).
- Software that provides support for healthcare professionals (e.g. ECG interpretation software).
- Software intended to process, analyze, create, or modify medical information when the software is governed by a medical intended purpose (e.g. searching image for findings that support a clinical hypothesis as to the diagnosis or evolution of therapy)
- Independent software, by having its intended medical purpose
Software 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). With the transformational impact of technology shaping the medical device sector, Celegence’s expert team can provide regulatory guidance and supplement information on whether your device qualifies as a MDSW.
With regards to software medical devices, changes to classification have been a leading cause for concern. In classifying software as a medical device, Rules 9, 10, 11, 12, 13, 15, and 22 of Annex VIII EU-MDR 2017/745 are to be applied. Nearly all software medical devices are likely to be class IIa, or even class III (the highest risk category), where previously the majority have been class I. This potential up-classification can be attributed to the wide-phrasing of Rule 11 which was newly added to Annex VIII of the EU MDR.
This rule was issued with guidance from the International Medical Device Regulators Forum (IMDRF). The drafting of Rule 11 assigns a significant proportion of software medical devices to the higher classes and manufacturers have taken a cautionary approach to this rule. The implication of such strict wording has led to increase in class contingent irrespective of the probable innocuous function of the device itself. For e.g., in cases were the software performs a relatively simple function, but if the resulting decision of the device itself could impact the well-being of the patient, the device is awarded the highest risk category. This may place additional strain on the manufacturer to place the device on market.
The Medical Device Coordination Group (MDCG) Guidance on Qualification and Classification of Software, appears to soften the impact of Rule 11, providing greater clarity with regards to classification of software medical devices. It particularly describes and categorizes the significance of the information provided by an active device to the patient management in combination with patient condition by dividing them into three sub-rules.
For further details on classification rules, please refer to:
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
Rapidly improving technology has made Software medical devices increasingly prevalent in the healthcare sector. Securing data being stored or processed by MDSW’s has become a valid concern for manufacturers not only in the development phase but also during the product maintenance.
Susceptibility to malware is a scaling concern as the software component in several MSDW’s becomes more complex. Manufacturers must be prepared to assess security risks, detect compromise, and recover from any data breach incidents.
Designing patent protection and copyright registrations are some of the primary measures that can be taken to protect MDSW’s. Additionally, cybersecurity measures based on cryptography, digital signatures, and frequent integrity checks, may help protect system programs and data against unauthorized manipulation.