Is the product a medical device in Europe?

AI Quick Summary

I would like to bring up the need to have clear claims for the tool. It is important that the intended purpose is clearly stated so that there are no unexpected legislative surprises. Using terms such as "diagnosis" in advertising implies that the app functions as a medical device, which would significantly increase the regulatory effort, time and cost required before it can be made available. Careful consideration should therefore be given to how the intend use of the app is described and communicated.

Project Idea Metadata

• Project Idea Name: Is the product a medical device in Europe?
• Date: 3/10/2025 6:21:15 PM
• Administrators:

Project Idea Description

I would like to bring up the need to have clear claims for the tool. It is important that the intended purpose is clearly stated so that there are no unexpected legislative surprises. Using terms such as "diagnosis" in advertising implies that the app functions as a medical device, which would significantly increase the regulatory effort, time and cost required before it can be made available. Careful consideration should therefore be given to how the intend use of the app is described and communicated.