The implementation of the European Union (EU) Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) sees the introduction of a Unique Device Identification (UDI) system for medical devices. A UDI guidance document from the Medical Device Coordination Group (MDCG) has recently been updated with a new section covering devices with a maximum number of reuses.
This section of the guidance has been added to support provision 17 of Annex VI Part B of the MDR which states that the manufacturer shall include the maximum number of reuses of a particular device (if applicable) in the UDI database.
Applicable devices are those where as a result of clinical evidence and the risk management process, a manufacturer has identified a maximum number of reuses of a device. For instance, this may be through evidence of degradation or deterioration beyond a certain number of re-uses. Examples of some applicable devices include:
- Minimally invasive robotic instruments
- Larynx masks
- Surgical instruments (scalpels, curettes, clamps, drills, burs)
- Endoscopic devices (biopsy forces, polyp retrieval basket).
The maximum number of re-uses is unique to each device and is impacted by multiple factors such as the material, the user and relevant process changes. Where a number is established by the manufacturer, this number shall be provided to the UDI database in EUDAMED along with the instructions for use.
It is important to note that the MDR does not require a maximum number of re-uses for all re-usable devices, this provision only applies to devices where such a number has been identified (hence the guidance on what is considered applicable). In instances where a maximum number of re-uses for a product is determined, a change to this data element will require a new UDI-DI to be issued.
For more information, click here.