Indicative qualification and classification aligned with MDCG 2019-11 and related guidance.
Describe your product or software — what it does, who uses it, and what health-related decisions or actions it influences.
Per MDCG 2019-11 rev.1, your stated intended purpose (label, IFU, promotional material) drives qualification — be as specific as you can.
Please enter a brief description (at least 20 characters).
Question 1 of 3
Is the product purely software, a physical device, or a combination?
Does the product diagnose, predict, monitor, or treat a medical condition?
Is the product already in clinical use, or is it still in development?
Please select an option to continue.
This is indicative guidance only and does not constitute regulatory advice.