🚫 Can you escape medical device regulation with a disclaimer?

Some companies believe that adding a label saying:
“⚠ This is not a medical device”
is enough to avoid regulation.

It’s not.

📌 Regulators look at the *intended purpose* and how the product is actually used — not just the sticker on the box.

If your product:
✔ Makes medical claims
✔ Supports diagnosis or treatment
✔ Influences clinical decisions

…then it may still qualify as a medical device under MDR, IVDR, or FDA rules.

A disclaimer cannot override the real function of the product.

That’s why defining your intended use correctly is one of the most critical regulatory decisions a manufacturer can make.

#MedicalDevices #MDR #IVDR #RegulatoryAffairs #SaMD #Compliance #MedTech #HealthcareInnovation

Видео 🚫 Can you escape medical device regulation with a disclaimer? канала Easy Medical Device