Is Lot Number required in addition to UDI serial number?

[SGquality]

We had a very interesting discussion this morning where the team was split in use of both Lot Numbers and UDI serial numbers. We will be having a new Class II medical device where each of the units (these are small units and not huge capital equipment) will have a UDI serial number. These units are contract manufactured in China.

The question is if Lot Number is required or would UDI be alone acceptable to demonstrate traceability?

 

[Susan]

Hi

I have similar questions as following about lot No. and serial No. in EU MDR.
(We have a class IIa disposable product in EU market and lot No. is included in label but without a serial No.)

What do you think of it? Looking forward to your opinions.
Thank you in advance!!

Question :

• Did I get the following right?

1. A serial number is just a optional code which may be included in UDI-PI. Serial no. is not mandatory for devices like disposable class I or IIa devices. (Of course except for some specific device like implantable devices )
   
2. If a serial number don't appear on the lable, there is no need to include it on UDI-PI.
   (As a disposable class I or IIa device )
   

Annexes VI in MDR
1. Definitions
"... The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date... "

3. The UDI 3.5
" 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... "


Thanks in advance!
Susan

 

[Ronen E]

We had a very interesting discussion this morning where the team was split in use of both Lot Numbers and UDI serial numbers. We will be having a new Class II medical device where each of the units (these are small units and not huge capital equipment) will have a UDI serial number. These units are contract manufactured in China.

The question is if Lot Number is required or would UDI be alone acceptable to demonstrate traceability?

What's the rationale for requiring the lot number in addition to the serial number?

 

[Susan]

What's the rationale for requiring the lot number in addition to the serial number?

Excuse me for cutting in.

I'm a little bit confused about lot No. and serial No. in MDR.
I can hardly find any explanation in MDR about assignment of UDI-PI for different classifications of device.
It seems that both serial number and lot number are needed in UDI-PI , as indicated in following definitions.

<Annexes VI 1. Definitions >
"... The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date... "

However, for example as for disposable devices of class I and IIa , it sounds more realistic to manage manufacturing by lot no..
Is it reasonable to think that there's no need to include serial no. in UDI-PI, if lot no. has been showed already for disposable devices of class I and IIa?

Could anyone share your opinions?

Thanks!

 

[Ronen E]

It seems that both serial number and lot number are needed in UDI-PI , as indicated in following definitions.

<Annexes VI 1. Definitions >
"... The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date... "

I fail to see how the quoted text leads to the above conclusion.

 

[Susan]

I fail to see how the quoted text leads to the above conclusion.

Thanks for your reply.
Maybe I didn't interpret the quoted text correctly.

What do you think of UDI assignment for medical devices of different classifications?
Should Serial no. and/or lot no. be showed in label for all medical devices?
I failed to find any explanation in MDR about that.

Could your share your view about that?
Thanks in advance.

 

[somashekar]

We make devices that have serial # as well as lot #
Devices having serial # are also made in lots of our handle-able quantity and will have a lot #
The way is such that the serial # will be an extension of the lot #
So for example it can be ABCnn if it is just with lot # and ABCnnxxx if it is Serial #
This complete gets into the UDI

 

[duinyk]

From the information below, it seems Serial Numbers as part of UDI-PIs are required only for implantable and reusable devices.


ANNEX VI Part 6.1.2.




The UDI-PI shall have at least the following characteristics:

(a)
the serial number for active implantable devices,

(b)
the serial number or lot number for other implantable devices.



6.1.3.

The UDI of the implantable device shall be identifiable prior to implantation.


6.2. Reusable devices requiring cleaning, disinfection, sterilization or refurbishing between uses


6.2.1. The UDI of such devices shall be placed on the device and be readable after each procedure to make the device ready for the next use.


6.2.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.