Information on the maximum number of reuses of devices and their implications on UDI for MDR 2017/745 compliance was recently provided by the MDCG in the Guidance on BASIC UDI-DI and changes to UDI-DI (initially published in 2018), in the fourth revision. In the following you will find all relevant information summarized:
If a product is not marked as single use, then a maximum number of reuses can be specified. Based on Part B, Annex VI of the EU Regulation 2017/745, the manufacturer shall provide “if applicable, the maximum number of reuses” of a device to the UDI database. The mention “if applicable” implies that it is not a mandatory UDI-DI field. Therefore, you must provide it if you have already determined by tests or evidences a number of uses after which the product is no longer properly usable.
In addition:
→ If you provide a number of reuses to EUDAMED, you must as well include this number to the instructions for use (MDR, Annex I, GSPR 23.4 (n)).
→ If this number changes, then a new UDI-DI must be assigned to the device.
Note that for devices already qualified as re-usable, the maximum number of reuses is in general not required.
In our EUDAMED MDR / IVDR Excel Template you can manually enter the number of reuses, or notify if it is a single use product. Using this template is the easiest way to prepare and collect data for upload to EUDAMED.
Learn more about this template here.
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