Rules for specific device types

A configurable medical device consists of several components which can be assembled in multiple configurations.

A configurable device UDI-PI shall be assigned to each individual configurable device. It is important to note that no UDI-PI information can be included in the UDI database.

The UDI system should apply to all devices, except custom-made and performance study/investigational devices.

Devices that are reusable shall bear a UDI carrier on the device itself.

The UDI carrier for reusable devices that require disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device.

The UDI carrier shall be readable during normal use and throughout the intended lifetime of the (reusable) device.

The requirements shall not apply to the device in case of the following circumstances:

Systems and procedure packs shall undergo a UDI registration, as described in Article 29(2) of MDR. Before placing on the market a system or procedure pack pursuant to Article 22(1) and (3), that is not a custom-made device, the system or procedure pack producer shall assign to the system or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI, and shall provide it to the EUDAMED database together with the other relevant core data elements listed in the MDCG 2018-4 Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs guidance document.