The Medical Device Coordination Group (MDCG) has recently published a useful guidance on the Implant Card (IC) according to article 18 of the MDR.
It makes sense to review the document in detail, so if this requirement applies to one of your products, please let us know and we will send the complete version to you. Below, we condensed some of the main aspects for a first overview. The guidance document suggests to include the following details on the IC:
- Device name;
- Device type;
- Serial number or, where applicable, lot or batch number;
- Unique Device Identification (UDI); the UDI as AIDC4 format and the UDI-DI as HRI5
- Name and address of the manufacturer of the medical device;
- Website of the manufacturer of the medical device.
The guidance also suggests the usage of a supplementary leaflet to include the explanation of symbols, the instructions how to complete the IC and also to adhere to the language requirements. Finally, there are useful insights about symbols to be used and design examples of ICs.
Source: MDCG guidance on implant cards
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