UDI and EUDAMED are two KEY new features of the MDR. But practically speaking, as a manufacturer, what will you actually be required to do? Let’s recap!
1) To get started, you will need to assign a UDI to the device and all higher levels of packaging and assign a basic UDI-DI to the device model.
What does “assign” mean? It is the production of a code according to a standardized coding structure. GS1, HIBCC, ICCBBA and IFA have published various resources to clarify this point!
2) Next, you will have to place the UDI carrier on the device or its label, and on all the higher levels of packaging.
Save for some exceptions, two means of affixing the UDI must be used:
- the HRI (Human Readable Information) ie. the numerical or alphanumeric code
- and AIDC (Automatic Identification and Data Capture): bar codes, QR codes, Data Matrix, RFID …
3) Finally, you will have to make various registrations in EUDAMED:
– First, a prerequisite: registration of your status in the electronic system on registration of economic operators,
– Second, the registration of your devices in the electronic system for registration of devices
– And finally, the registration of the UDI-DI and all related information in the UDI database.
Assign, Affix, Register, 3 key concepts to remember !
And don’t forget that different dates of application are associated with each of these obligations.
More info regarding dates will be provided in a future episode of “The Regulatory Minute” !
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