Is a lot number or serial number on the label always required by EU MDR Annex 23.2(g)? Or does the "as appropriate" instead mean that neither a lot number nor serial number may be required?
This is a basic Good Manufacturing Practice (GMP) requirement/expectation which has been in place for many years. While regulations may give an option of a serial number or lot number, from a post market perspective it would be a nightmare to manage. And again, it is a GMP fundamental which is in place now. Imagine having to recall a product with no lot number, a company may have to recall much, much more product than if there were distinct lot numbers or serial numbers assigned. From a GMP perspective, I would read "as appropriate" as either a serial number or lot number, not neither. As appropriate could also mean use of a symbol or not. As appropriate could also refer to where a serial or lot number are placed on the device label, if there are multiple levels of packaging.
I agree with the longstanding adage that, if there is no lot number or serial number, then a manufacturer may need to recall a wider swath of units than might otherwise be necessary compared to when the units instead contained a trace number like lot, batch, or serial number. But though it may be wise to always have a lot or serial number, I'm not sure that we can say it is a legislative requirement that all devices shall have a lot or serial number. A few of my thoughts on that are given below. Looking forward to seeing the remainder of this interesting discussion.
------------------------------Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)Principal ConsultantRidgway, COUnited States© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.------------------------------
------------------------------Richard Vincins ASQ-CQA, MTOPRA, RACVice President Global Regulatory AffairsOriginal Message:Sent: 22-Sep-2023 21:00From: Anonymous MemberSubject: EU MDR Annex 23.2(g): Is a lot number or serial number always required?This message was posted by a user wishing to remain anonymous
Annex I (23.2)(g) does not stand alone.
The "as appropriate" depends on how you control the manner of production. If it is by lot number, then the lot number is on label, similarly for serial number, and similarly for both.
Annex VI, Part B, 3 says, the UDI database includes "the manner in which production of the device is controlled (expiry date or manufacturing date, lot number, serial number)". This database entry will match what is on the label.
Annex VI, Part B, 3.5. says, "If a lot number, serial number, software identification, or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI."
So, the manufacturer decides the manner to control production. That decision determines the information on the label, the information in the UDI database, and the information in the label's UDI-PIs.<o:p></o:p>
In addition to the extended reply by Kevin Randall, I like to add a pragmatic approach. As Richard VIncins mentions, you must be able to track and trace a device and recall it, if necessary. You need to find the right balance in investing into identification of seperate batches and the possibility and costs of a recall. In calculating the potential costs of a recall, the factor of not having the device available to users should also be factored in. It could result in long term decreased market share.
The Regulations grand the manufacturer to decide on the granularity of the UDI-PI (PI = Production Identifier). Carefully consider the options and aply this choice consistently. Justify this in the technical documentation in the labeling section and evaluate this strategy via PMS.
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