18 Oct Medical Device Software – Class I
Can medical device software still be classified as Class I software under EU MDR 2017/745?
There is an ongoing discussion about whether medical device software can be classified as Class I under EU MDR 2017/745. Here is my assessment based on EU MDR 2017/745, MDCG 2019-11, MDCG 2020-16, and MDCG 2021-24:
EU MDR Classification Rule 11:
This rule states:
” Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
- death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or
- a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
All other software is classified as class I.”
Class I criteria for Medical Software:
Based on the classification definition according to Rule 11, medical device software can be qualified as a Class I medical device. Here are the criteria that must be met:
- Have a clear medical purpose
- Not be used for a purpose specified in higher risk classes
- Not drive or influence the use of a higher-class medical device
- Perform simple actions beyond storage, archival, communication, support, or basic search functions
Examples:
Here are two examples of software that could potentially be classified as Class I under the EU Medical Device Regulation (MDR):
1.) Simple exercise guidance software: Applications that provide instructions for physical exercises to patients, such as eye exercises or pelvic floor exercises, without monitoring physiological processes or providing diagnostic/therapeutic decisions.
2.) Behavioral change practice software: Applications designed to help patients practice behavioral changes, for example, in managing addictive behaviors, without providing medical diagnoses or treatment decisions.
Conclusion
In conclusion, while it is possible for medical software to be classified as Class I under the EU MDR, the criteria are quite stringent. Many types of medical software will fall into higher risk classes due to their functionality and potential impact on patient health. Manufacturers must carefully assess their software’s intended use and functionality against these classification rules to determine the appropriate class. For such products, I recommend consulting a Notified Body to get more clarity.
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