Can clinical evaluation for a Class I SaMD app rely on literature from similar, but not equivalent, devices?

Question

I am working on the clinical evaluation for a mobile application (Class I, SaMD) that helps people quit smoking. The app features interactive therapy articles with quizzes, a calendar with badges for abstinence, and options for user or professional chat. There are existing CE-marked apps with similar intended purposes, but their features do not exactly match ours.
 We have not conducted a clinical investigation on our app. There are published studies on other apps targeting smoking cessation, but with differing features.
 According to MDCG guidelines, is it permissible to use a combination of studies on different apps for our clinical evaluation, even if none are strictly equivalent? Do we need to demonstrate equivalence in this case, or can we rely on literature and data from similar, but not equivalent, devices? What type of data is minimally required to demonstrate technical and clinical performance if we do not use equivalent devices?
 Any clarification on practical approaches to this situation would be appreciated.

Dr. Oliver Eidel · Accepted Answer

You can use data from equivalent devices for your clinical evaluation, but you are not required to do so. If you want to use literature on other devices, you need to describe how those devices are equivalent to yours, focusing on technical and clinical aspects (intended purpose, mode of action, target users, etc). For SaMD, biological equivalence is generally not relevant.
If you do not have clinical investigations or strictly equivalent devices, you should still demonstrate that your device performs as intended and that its benefits outweigh the risks. This can be done using a combination of literature, scientific rationale, and, if possible, post-market data or surveys. MDCG 2020-5 offers guidance on how to substantiate equivalence, but for Class I devices, the requirements are less stringent than for higher classes. The more closely the literature matches your app's features and intended use, the stronger your justification will be.
In summary, you can rely on published studies and data from similar devices, but you should clearly explain any differences and provide a scientific justification that your app is likely to perform as intended based on the available evidence.

Answer

It really depends on your particular device. If you provide more details about its features and intended users, people here might be able to give more tailored advice. In general, equivalence in clinical evaluation is complex, and for higher risk devices it's much stricter. For Class I, you do have more flexibility, but your rationale should still be well documented.

Answer

It really depends on your particular device. If you provide more details about its features and intended users, people here might be able to give more tailored advice. In general, equivalence in clinical evaluation is complex, and for higher risk devices it's much stricter. For Class I, you do have more flexibility, but your rationale should still be well documented.

Can clinical evaluation for a Class I SaMD app rely on literature from similar, but not equivalent, devices?

3 Answers

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