“Maximum number of reuses of device” in EUDAMED
The implementation of Unique Device Identification (UDI) means that medical device manufacturers are obliged to provide health authorities such as the EUDAMED with a comprehensive range of product information. Among all this information the manufacturers needs to inform about the maximum number of reuses of device.
This information is particularly important for products where clinical evidence and risk management procedures set a limit value.
The document MDCG 2018-1 Rev.4 provided by the MDCG in the Guidance on BASIC UDI-DI and changes to UDI-DI outlines the requirement for manufacturers to specify the maximum number of times a device can be reused, if applicable. In the following you will find all relevant information summarized:
For products not designated for single use, manufacturers have the option to specify a maximum reuse count, they are advised to submit, “if applicable, the maximum number of reuses” to the UDI database.
Whilst the maximum number of re-uses depends on multiple factors such as the material, the user and relevant process changes, examples of devices where this requirement could apply include:
• Minimally-invasive robotic instruments
• Larynx masks
• Surgical instruments : scalpels, curettes, clamps, drills, burs
• Endoscopic devices: biopsy forceps, polyp retrieval basket
When filling out the “maximum number of reuses” Information, the following points should be noted:
→ 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.
→ The mention “if applicable” implies that it is not a mandatory UDI-DI field. For devices already qualified as re-usable, the maximum number of reuses is in general not required.
Whether in our SAP Add On or our Excel spreadshit, our solutions for optimal data management allow you to manually enter the number of reuses or indicate whether it is a single-use product. Using this template is the easiest way to prepare and collect the data to be uploaded to EUDAMED.
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