How to label a model 'not for clinical use'

In the EU, a device's "intended purpose" is "the use for which a device is intended according to the data supplied by the manufacturer on the label", the instructions and the promotional or sales materials [1]. The UK's MHRA looks at "the claims about what the product is and what it does (explicit and implicit)" [2]. So the words around a model matter as much as the model.

The label we ask makers to use

Education and display model. Not a medical device. Not for diagnosis, treatment planning or use in the body.

For prototypes, use: "Prototype. Not for patient use."

Steps

1. Write the purpose in the job post: teaching, display, practice or prototype.
2. Ask for the label printed or embossed on the base, or on a tag tied to the model.
3. Check every description you write later (a course handout, a listing, an event sign) for claims.
4. Keep the model generic: never name a patient or use their scans.

Claims to keep out

• "For diagnosis", "for surgical planning" or "for treatment".
• "For patients with…" or "relieves", "treats", "prevents".
• "Medical grade", "sterile" or "biocompatible".
• Testimonials that suggest a medical result: the MHRA treats testimonials as implied claims, and says general disclaimers are not acceptable if medical claims are made or implied elsewhere [3].