Why, how, and where to present product instructions

Q&A on using product instructions

Q: Why is it important to present instructions?

A: Instructions for Use is an accompanying document for every registered medical device (which includes all modules developed by Infermedica). Instructions for Use is subject to the supervision of the relevant institutions and therefore cannot be freely edited. Instructions for Use must be comprehensible to the user, warn them of the risks associated with the use of the product, and clearly describe the intended use of Infermedica’s modules (e.g., Infermedica Triage and Symptom Checker).

Q: How can users use them?

A: In Instructions for Use, the user can see the module’s manufacturer and how to contact them. The user will also learn about contraindications to using the product as well as situations in which they should stop the symptom assessment and contact their doctor immediately.

Q: Where is the Instruction of Use located?

A: Instructions for Use is part of the documentation provided with Infermedica’s modules, and you will receive it during the implementation process. In the case of an API product, it is the customer’s responsibility to create the instructions if their final application will be a medical device as defined by Medical Device Regulation (EU) 2017/745.


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