The EU Medical Device Coordination Group recently published a much-anticipated guidance on the qualification and risk-classification of software falling within the scope of the new medical device regulations, which take effect in less than six months for medical devices and in 2022 for in vitro diagnostic medical devices.

The new guidance, which is targeted at manufacturers of medical software, clarifies the criteria for the qualification of software falling within the scope of the new medical device regulations and provides guidance on the risk-classification of such software under the new regulations. With the use of illustrative examples and flowcharts, the guidance is a helpful tool for manufacturers of software solutions and applications for the healthcare industry.

Medical Device Software

The primary focus of the guidance is to provide sufficient means for software manufacturers to identify whether specific software products fall within the scope of the new Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

In this context, the guidance defines “software” as “a set of instructions that processes input data and creates output data”.

So-called Medical Device Software (MDSW) covered by the new regulations is defined as software that is intended to be used, alone or in combination with a device, for a medical purpose regardless of whether the software is independent or driving or influencing the use of a device. Software manufacturers may thus start by asking themselves:

  • Is the software covered by the definition “software”?
  • Does the software have a medical purpose? In this regard, it is the manufacturer’s intended purpose of the software that is relevant, and not the actual use (or misuse) of it.

The guidance also provides a number of illustrative examples showing the types of software that falls within the scope of the regulation(s).

For example, software intended to process, analyze, create or modify information may be qualified as a medical device software if an intended medical purpose governs its creation or modification. Software which alters the representation of data for a medical purpose would also qualify as a medical device, whereas software that alters data for cosmetic or compatibility purposes and software used for planning, invoicing  or for simple searches would not qualify as a medical device falling under the new regulations.