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What is the classification of my software? – Elexes
Elexes Medical Consulting

AI/ML changing the medical device industry

Artificial Intelligence/Machine Learning based Software has revolutionized the medical device industry; allowing the Health Care Practitioners and Patients to receive more definitive results quickly by providing quantitative scores which relate to clinical conditions, it has also facilitated learning from real-time experiences and subsequently enabling the development of future versions of the software with enhanced features and functionalities. 

Classification of software 

A medical device has its own classification (in the US – Class I, II or III; in EU I, IIa, IIb, III), but the software used in medical devices, or stand-alone software that work based on an input form a medical device has a different classification, referred to as the level of concern. E.g., A medical device could be a Class II device, but its software can be a major level of concern. 

What is the level of concern?

Level of Concern (LoC) is a classification that is derived based on the severity of an injury to a patient either in a direct or an indirect way due to device failure, design flaws or the usage of the device for its intended use.

Why should I have to consider this?

If a medical device’s intended use is achieved by the use of software, or a mobile app qualifies as a medical mobile app, or a stand-alone software qualifies as a medical device, then these requirements are very important to be considered.

Under which level of concern will my software fall?

To classify software there are various questions that one would have to address. Check what your level of concern might be – 

Major Level of Concern 

If the answer to any one question below is Yes, the Level of Concern for the Software Device is likely to be Major. 
1. Does the Software Device qualify as Blood Establishment Computer Software? (Blood Establishment Computer Software is defined as software products intended for use in the manufacture of blood and blood components or for the maintenance of data that blood establishment personnel use in making decisions regarding the suitability of donors and the release of blood or blood components for transfusion or further manufacture.) 
2. Is the Software Device intended to be used in combination with a drug or biologic? 
3. Is the Software Device an accessory to a medical device that has a Major Level of Concern? 
4. Prior to mitigation of hazards, could a failure of the Software Device result in death or serious injury, either to a patient or to a user of the device? Examples of this include the following: 
a. Does the Software Device control a life-supporting or life-sustaining function?
b. Does the Software Device control the delivery of potentially harmful energy that could result in death or serious injury, such as radiation treatment systems, defibrillators, and ablation generators? 
c. Does the Software Device control the delivery of treatment or therapy such that an error or malfunction could result in death or serious injury? 
d. Does the Software Device provide diagnostic information that directly drives a decision regarding treatment or therapy, such that if misapplied it could result in serious injury or death? 
e. Does the Software Device provide vital signs monitoring and alarms for potentially life-threatening situations in which medical intervention is necessary?

Moderate Level of Concern 

If the Software Device is not a Major Level of Concern and the answer to any one question below is Yes, the Level of Concern is likely to be Moderate. 
1. Is the Software Device an accessory to a medical device that has a Moderate Level of Concern? 
2. Prior to the mitigation of hazards, could a failure of the Software Device result in Minor Injury, either to a patient or to a user of the device? 
3. Could a malfunction of, or a latent design flaw in, the Software Device lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury? 
If the answers to all of the questions in Tables 1 and 2 above are No, the Level of Concern is Minor. 

How does the level of concern help?

Level of concern helps you understand what is that you are up against, how many requirements you would have to meet, and documentation you would have to provide to get your product to the market. 

A minor level of concern software can satisfy the pre-market submission requirements with basic documents, while Major and Moderate levels of concern software need to submit more documents and the hazard analysis has to be very robust. 

An overview of what is needed?

Level of Concern Documents Required

Major
– The Rationale of LoC
– Software Description
– Hazard Analysis
– Documents to support safety and efficacy

Moderate
– The Rationale of LoC
– Software Description
– Hazard Analysis
– Documents to support safety and efficacy
Minor– Basic Documents 

I hope this helped you identify your software’s classification. For questions and concerns please feel free to write to us at jennifer@elexes.com.

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