Dive Brief:

• With a little more than half a year until the compliance deadline for the Medical Device Regulation (MDR), the European Commission's Medical Device Coordination Group (MDCG) issued new guidance Friday aimed at clarifying which types of software will be regulated under the new rules and how they ought to be classified and placed on the market. It also offered guidance on which software falls under the In Vitro Diagnostic Regulation (IVDR), which takes effect May 2022.
• Medical device software (MDSW) is likely to be covered by MDR or IVDR if it is intended to be used together with one or more medical device or in vitro diagnostic and will specifically enable the product to be used for its intended purposes, or specifically and directly assist the medical functionality of the product.
• MDSW that has 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." But in these cases, the MDSW's risk class cannot be lower than the risk class of the hardware medical device, the guidance said.

Dive Insight:

The regulatory status of medical device software is often murky but the MDCG is aiming to help manufacturers clarify when software is regulated under the new EU MDR and IVDR. In a 28-page guidance released Friday, the MDCG set out decision trees to help guide device makers's decisions.

The first decision tree features five steps to qualify MDSW while the second tree guides device makers on whether the MDSW would fall under the MDR as a medical device or under the IVDR as an IVD.

On MDSW qualification questions, some of the steps include deciding whether the software performs an action on data or performs an action beyond storage, [archiving], communication, simple search or compression and whether the action is performed for the benefit of individual patients. For example, software that just aggregates data or provides generic treatment advice likely does not qualify as MDSW.

MDSW may also have its own intended medical purpose apart from associated hardware, according to the guidance, and thus meet the definition of medical device or IVD on its own. The guidance gave the example of MDSW that uses maternal parameters garnered through fetal ultrasound exams for evaluating the risk of trisomy 21. Other examples include MDSW that measures and transmits blood glucose levels to drive an insulin pump to deliver correct insulin dosages and mass spectrometry MDSW that analyzes data to detect antibiotic resistance. 

Software can also qualify as MDSW regardless of whether it is operating on a mobile device, on the cloud or as added functionality on a hardware medical device. Software that is capable of directly controlling a medical device like radiotherapy treatment software and EKG interpretation software also qualifies as MDSW.

But not all software used in healthcare settings qualifies as MDSW, the guidance said, giving examples of software used for staff planning, invoicing and simple searches as software that wouldn't qualify as a medical device.

Nonetheless, if the software is aimed at processing, analyzing, creating or modifying medical information, it could qualify as medical device software if an intended medical purpose governs its creation or modification. For example, the guidance said software that alters the representation of data for a medical purpose would qualify, whereas software that alters data for cosmetic or compatibility purposes would not qualify.

The second decision tree helps device makers decide whether the MDSW qualifies as a medical device or as an IVD. Questions include whether the MDSW provides information within the scope of the in vitro diagnostic medical device definition, and if the MDSW creates information based on data obtained by IVDs only.

If the information is solely gathered from IVDs then the device is an IVD MDSW, the guidance said. If the data gathered is from both IVDs and medical devices, the next step is to determine whether the intended purpose is substantially driven by data sources coming from IVDs or from medical devices.

In cases where the intended purpose of the MDSW output fulfills both the medical device and IVD definitions, the manufacturer should weigh the data sources based on the significance of the information to decide which regulation applies, the guidance said.