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HL7 / emedicinal-product-info

Gravitate Health Project
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Could this be applied to medical devices? #109

Open joofio opened 1 month ago

joofio commented 1 month ago

Is it plausible to have a similar strucutre for medical devices, is the "epi" mandatory for MD as well? or if not mandatory, do they exist for a considerable amount?

if so, should we change the composition reference to be able to store device/devicedefinition?

cander2 commented 1 month ago

Yes, devices have their own labels as well.

FDA came up with this Unique Device Identifier (UDI) standard. I think this partly describes what would go in the device label and it looks like the DeviceDefinition covers UDI. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system

I've never checked to see if UDI and/or the DeviceDefinition covers 100% of the content in a device label. But I would think it was plausible given all that we have achieved with ePI.