I advise that devices that "can be", "re-assembled after their first use" for purposes of medical device maintenance and spare part replacement are not the direct intent or context of Annex VI.C.4.13. Instead, Annex VI.C.4.13 is for a different category of devices, specifically, those that "must be assembled before their first use" (even though these may indeed need to be re-assembled after subsequent maintenance).
For example, a device that comes assembled for the user but later requires disassembly for cleaning or reprocessing or maintenance after use would not be the intended focus of Annex VI.C.4.13. Instead, the former would simply be subject to other general UDI carrier requirements for any single finished device along with, as applicable, the requirements for reusable devices. And for such devices, the UDI need only be placed on one part (if at all) anyhow (notwithstanding packaging and labels); thus Annex VI.C.4.13 doesn't even need to be leveraged for such devices if one is simply trying to avoid having the UDI on multiple parts of the device.
Annex VI.C.4.13 is born from the IMDRF's approach to UDI and thus the IMDRF's approach is worthy of employing (per the MDR preface). I haven't seen that IMDRF principle be convoluted with device maintenance and spare part replacement.
Remember also that if the replaceable spare parts are Annex VI.C.3.6 components, then those would indeed need their own UDI.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 20-Oct-2023 05:43
From: Richard Vincins
Subject: Eu MDR_ UDI DM
Anon,
While the UDI requirements in the EU MDR/IVDR have specific requirements, there are still quite a few areas which still need to be addressed. The information you posted is correct, that if a device has multiple parts being put together as part of the initial assembly, then there is only the one (1) UDI needed. As an example, if you have a laser type of device with the main console, a screen, a handpiece, a cart, a moving arm, etc., these all need to be put together before the first use. The actual laser device, then just needs one UDI.
When looking at Unique Device Identification (UDI) it is more important how this is viewed from the user's perspective and not always about what the regulation says or does not say. If there is a spare part which needs to be tracked through the use activity then it should probably have a UDI. This way when there is a complaint or issue with the part or component, this is an easy way to identify the part. While there is no clarity in the regulation, spare parts, components, or other parts may benefit from UDI for traceability purposes.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 20-Oct-2023 02:20
From: Ronald Boumans
Subject: Eu MDR_ UDI DM
If the spare parts are just that and not devices in their own right, they don't need their own UDI. Article 23 specifies what should be considered a spare part. I would expect the IFU to specify what maintenance is needed.
If replacing these parts becomes a form of refurbishing, there is possibility of this involved legal person becoming the manufacturer.
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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
Original Message:
Sent: 19-Oct-2023 01:45
From: Anonymous Member
Subject: Eu MDR_ UDI DM
This message was posted by a user wishing to remain anonymous
Hi All,
EU MDR Annex VI Cluase 4.13. ''In the case of single finished devices made up of multiple parts that must be assembled before their first use, it shall be sufficient to place the UDI carrier on only one part of each device.''
Does this clause apply to finished devices made up of multiple parts that can be re-assembled after their first use? e.g. the device must be assembled before first use, however it can be disassembled/reassembled during it life as one or two of the components can be replaced (spare parts).
Thanks.