The Medical Device Coordination Group (MDCG), a special advisory body of the European Commission (EC) issued a detailed guidance on software classification according to the new medical device regulations: 2017/745 (MDR) and 2017/746 (IVDR). 

Medical Software Regulated by MDR/IVDR

The European Union’s Medical Device Coordination Group (MDCG) issued special guidance aimed to provide medical device manufacturers with the information necessary to simplify the qualification and classification of medical software. The guidance contains detailed criteria applicable to software intended for medical purposes. The rules provided by the guidance could be applied to desktop software, as well as applications (apps) intended for mobile devices, and also for the cloud solutions and any other form of the software both operating independently or as a part of the particular medical device. As the general definition, the MDCG utilizes the term “software” as a set of instructions used to process input data to get the output data, that actually covers all the examples provided above. At the same time, there are several special terms used to clarify the provisions, including the following:

  • Software driving or influencing the use of the device – a software that has not medical intent itself, but is necessary to maintain the operations of hardware device itself;
  • Medical Device Software (MDSW) – a software intended for medical purposes and regulated under the MDR/IVDR. 

Medical Device Qualification Criteria

As mentioned above, software should be intended for medical purposes by the manufacturer to be qualified as a MDSW. At the same time, if the software doesn’t meet the definitions of medical device software provided by the MDR or IVDR, but its manufacturer claims that it is intended for medical purposes, such software would also be subject to the regulations under the MDR/IVDR framework. In most cases, it would be regulated as an accessory to the medical device. According to the definition provided in the guidance, an accessory is an element that is not a medical device itself, but is intended by the manufacturer to be used with one or several medical devices in the course of their intended use or to improve their functionality. Such software could also be qualified as a part or component of a medical device. 

According to the general rule, the software could:

  • Directly control a medical device, or 
  • Provide information that is necessary to make decisions, resulting in immediate actions, or
  • Be utilized by healthcare professionals. 

It is important to mention that utilization by healthcare professionals itself could not serve independently as qualification criteria. This is because there are various types of software used by healthcare professionals to perform particular actions that do not qualify medical software due to the absence of direct medical purpose of use. For example, software used to get access to the database would be excluded from the regulation under MDR/IVDR based on this criteria. The guidance also provides other examples of the software excluded from regulation, such as software for invoicing or communications (mail, voice and video calls). At the same time, if the software in any way operates with medical data, performing such functions as processing, analyzing or modification, when there is data processed to obtain an output as the result of such operations, the software of this kind would be qualified as medical software due to its intent. 

According to the general rule, MDSW is a software intended by the manufacturer to be used alone or as a part of a medical device to achieve medical purposes. For example, the software qualified as MDSW could:

  • receive or use parameters to perform calculations,
  • drive hardware medical devices allowing it to perform its main intended actions,
  • be installed on any device or platform, including cloud solutions,
  • be used both by healthcare professionals and patients themselves.

The MDCG reminds medical device manufacturers that any claims related to the functions performed by medical software and its effectiveness should be supported by the data obtained as a result of clinical trials confirming such claims.

Medical App Qualification Steps

The guidance provides a detailed description of the step-by-step qualification procedure to define whether or not the particular software constitutes MDSW and falls subject to the regulation under the MDR/IVDR. For this purpose, the following steps should be followed:

  1. Check the compliance with the definitions of the medical device,
  2. Check whether the software meets the requirements set forth for the parts and accessories,
  3. Check the way the software operates with the data (whether it processes medical data to provide particular results in the form of output, or not), 
  4. Check the benefit for the particular patient (if, for instance, the software operates with the statistical data and thus provides no benefit for the particular patient, it would not be qualified as medical device),
  5. Check whether the software fits the definition of the MDSW provided in the guidance. 

The guidance also includes appropriate steps applicable for the software related to the In-Vitro diagnostics, taking into account the specific of this sphere. 

Rule 11 and Other Medical Device Classification Rules Under the MDR

The MDCG describes in detail a set of rules set forth by the MDR related to the classification of medical software. First of all, it is important to mention that according to the guidance, in the case that several classification rules could be applied for one particular medical device, the one that is the strictest should be applied. If the software is provided independently from any medical device, it should be evaluated independently too. The most of the risks associated with the medical software are related to the wrong interpretation of data and mistakes or errors in data processing. To deal with this issue, a special classification rule (Rule 11) was implemented. Rule 11 describes the risks associated with the information provided by the medical device. It includes two main elements: patient management, as a process of making important decisions based on the information provided by the medical software, and also the patient condition, describing the current situation. According to the Rule 11, any software that provides information used to make decisions related to the particular patients should be classified as Class IIa, except certain devices with the higher intrinsic risk, classified as Class IIb or Class III respectively – for example, software providing information used to make important decisions for the health of the patient that could lead to substantial consequences. Rule 11 also includes sub-rules a, b and c; describing separate aspects depending on the purposes (for example, monitoring purposes). 

The guidance also covers issues related to placing medical software to the market. According to the guidance, the software could be placed independently or as an integral part of a medical device. At the same time, the type of the connection between the software and medical device should not be taken into account while only the intended purpose and associated risk actually matter. 

RegDesk platform provides medical device manufacturers and medical software developers with the detailed and reliable information on the classification of the software intended for the medical purposes. Compliance with the regulations applicable to the medical software is important for all parties involved in the development of this innovative sphere.



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