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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?

Anon,

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.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 22-Sep-2023 21:00
From: Anonymous Member
Subject: 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

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?

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.

• Annex VI.C.3 states, "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 only a manufacturing date on the label, this shall be used as the UDI-PI.".  This seems to leave open the possibility that there might not be a lot or serial number.

• Annex VI.C.1 states that the different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.  This seems to leave manufacturers the flexibility of deciding on which type of traceability is appropriate.

• For software for example, the notion of recalling a wider swath of installs is a commonplace reality, as software is only required to show the software identification (i.e., the version), which approach doesn't necessarily allow a subset of production (i.e., installs) to be discerned.  Consequently, that generally requires all of the installs to be recalled. This reality can't comply with a mandate for a lot, batch, or serial number to narrow down a production batch.

• Annex I.23.2(s) clearly demands a serial or lot number for implantable devices, but not others.

• For reusable devices, Annex VI.C.6.2.2 states that the UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.  This seems to leave open the possibility that there might not be a lot or serial number.

• The MDR aims to harmonize with the IMDRF.  The IMDRF's final document IMDRF/GRRP WG/N52 FINAL:2019 on labeling indicates that the label "should" include the batch code, batch number, lot code, lot number, serial number, control number, or version number of the medical device or IVD medical device, as appropriate. But "should" doesn't mean "shall", and "as appropriate" typically means that the manufacturer has the liberty to decide that such aspect might not be appropriate.

• Globally, it is commonplace that many devices don't require a lot or serial number, such as under the FDA and Canadian jurisdictions.  Europe's legislative nod for accepting the IMDRF approach seems to indicate that Europe recognizes the value of global harmonization.  In contrast, mandating lot or serial numbers for all devices regardless of risk, complexity, type, etc., would seem to be out of step with such a harmonization principle, and also with the fundamental realities of medical device manufacturing where delineation of definitive production batches (beyond manufacturing date) is not always possible.

• Annex VI.B.3 describes the manner in which production of the device is controlled as "expiry date or manufacturing date, lot number, serial number" which seems to leave sensible flexibility for choosing an appropriate way to trace production, such as via a manufacturing date rather than a serial number or lot number.  Indeed, the nature of some manufacturing processes don't lend themselves to defining discreet manufacturing batches, such as devices made across multiple extended or separated time slots by multiple manufacturing operators.

• Under the MDD, the originating requirement was, "Where appropriate, the batch code, preceded by the word 'LOT', or the serial number", which I always interpreted to mean that there may be no batch code, lot, or serial number. I haven't seen definitive evidence that this longstanding approach was changed for the MDR.

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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: 23-Sep-2023 03:36
From: Richard Vincins
Subject: EU MDR Annex 23.2(g): Is a lot number or serial number always required?

Anon,

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.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 22-Sep-2023 21:00
From: Anonymous Member
Subject: 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

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?

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.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 22-Sep-2023 21:00
From: Anonymous Member
Subject: 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

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?

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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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
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Original Message:
Sent: 22-Sep-2023 21:00
From: Anonymous Member
Subject: 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

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?