The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, focused on further improving the regulations in the sphere of medical devices, has published a new visual guide describing the approach to be applied when determining whether software in question is a medical device.

The scope of the document covers both medical device software and in vitro diagnostic medical device software. According to the document, medical device software (MDSW) is defined 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 Medical Devices Regulation 2017/745 (MDR) or In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). 

Regulatory Background 

The approach to determining whether software subject to review is a medical device, as described in the present guide, is based on the MDCG guidance on qualification and classification of software under MDR and IVDR published earlier in October 2019. 

The aforementioned document outlines the criteria to be applied for such determination and is intended to provide the medical device manufacturers and other parties with additional clarifications and recommendations on the matter. The document also describes certain aspects related to placing medical software on the EU market. It is important to note that the approach described in the document could also be applied in the case of mobile applications, as well as ones operating as cloud-based services. Hence the same approach should be applied irrespectively of the particular platform the software is based on. 

First, the document provides the definitions of the most important terms used in the context of the medical device software, namely: 

 

  •  Intended purposethe use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use, or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation. 
  • Accessory – an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical device functionality of the medical device(s) in terms of its/their intended purpose(s). The MDCG additionally mentions that the software accessory may be driving or influencing the use of a medical device. Moreover, the instructions for use and other documentation provided by the manufacturer should contain details about the way the appropriate software and accessories should be selected. 
  • Software stands for a set of instructions that processes input data and creates output data. 

 

One of the most important concepts referred to in the MDCG guidance is software driving or influencing the use of a device. According to the document, this concept covers software that does not have stand-alone functions and is intended solely to drive a hardware medical device’s operations. Such software could be intended to operate or control a hardware medical device or supply the output. Software of this kind could also be qualified as an accessory to a medical device.

Medical Device Software Determination 

 The first flowchart describes the approach to be applied in the case of general medical device software. According to the flowchart, the software in question should be subject to regulation if it meets the following criteria:

  • It meets the definition of a medical device, an accessory thereto, or drives the operations of the medical device, or
  • It performs additional processing of data (not only storage or communication), and its action creates benefits for the patients and also meets the definition of medical device software in accordance with the aforementioned MDCG guidance. 

 

Should software subject to review fail to meet the criteria provided above, such software would fall outside the scope of the medical device regulations. 

 

In Vitro Diagnostic Medical Devices Software Determination

 Aside from the general medical device software, the MDCG also provides a flowchart describing the approach to be applied with regard to the products intended for in vitro diagnostic purposes. 

To ascertain whether the software in question should be subject to regulation under the framework for the medical device, the interested party shall determine whether it meets the following criteria: 

 

  • It meets the definition of a medical device, an accessory thereto, or drives the operations of the medical device, or
  • It provides the information usually provided by in vitro diagnostic medical devices, and it also provides only the information collected from an in vitro diagnostic medical device, or 
  • The intended purpose of the software is related to IVDR matters. 

 

Both flowcharts described above are intended to assist medical device manufacturers (software developers) in determining whether the software products they are going to place on the market are subject to regulation under the applicable medical device framework. 

Medical Device Software: Marketing and Conformity Assessment 

 

The MDCG guidance on the classification of the software intended for medical purposes also highlights additional important aspects to be considered by the parties involved. 

 In particular, it is stated that the type of interconnection between the medical device software and the device does not affect the qualification of the software as a device under the MDR and IVDR (e.g. whether the software is incorporated in a device or is at a different location). Medical device software could exist either as a stand-alone product or be incorporated in a hardware device. 

 The guidance further clarifies the regulatory requirements related to both types of software mentioned above, namely: 

 

1. Medical device software as a stand-alone product should be subject to the full scope of the regulatory procedures in accordance with the applicable legislation considering its qualification and classification. 

2. Medical device software that is an integral component or part of a hardware medical device could be placed on the market under the simplified procedure. In particular, it would be subject to review not separately, but in the course of the general assessment of the hardware medical device itself. The MDCG additionally emphasizes the importance of considering the intended purpose of the software. 

 

Another important concept addressed in the MDCG guidance relates to the modules a medical device software could have. The MDCG acknowledges that some of such modules could have a medical purpose, while others may not. 

In order to clarify the concerns arising in regard to the regulatory status of such software, the MDCG states that the modules falling within the scope of the medical device framework should comply with the regulatory requirements applicable thereto. Consequently, they should be marked with the CE marking. At the same time, the modules that are not intended for medical purposes, are not required to comply with the regulatory requirements for medical devices. 

Summarizing the information provided above, the MDCG has developed detailed recommendations to be considered by the medical device manufacturers (software developers) and other parties involved. These recommendations cover the most important aspects related to the classification of medical device software and the determination of the regulatory requirements to be applied. 

How Can RegDesk Help?

 

RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.

Sources:

https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2021_mdsw_en.pdf

https://ec.europa.eu/docsroom/documents/37581

 


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