MDCG Guidance on Basic UDI-DI

Updated guidance was just published by the MDCG to better clarify the notion of Basic UDI-DI, its usage and when a UDI-DI requires changes.

The MDCG states:

”The Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and essential design and manufacturing characteristics.

It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item.

Any Basic UDI-DI shall identify the devices (group) covered by that Basic UDI-DI in a unique manner.”

Both the CE Certificate and the declaration of conformity should contain the Basic UDI-DI.

Which factors trigger change in UDI-DI?

“A new UDI-DI shall be required in the case of any change of the following elements: name or trade name, device version or model, labelled as single use, packaged sterile, need for sterilization before use, quantity of devices provided in a package, critical warnings or contra-indications (e.g. containing latex or DEHP), CMR/Endocrine disruptors”.

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