SBS - The best value in QMS software

Is Lot Number required in addition to UDI serial number?

SGquality

Quite Involved in Discussions
#1
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?
 
Elsmar Forum Sponsor
#2
Hi :bigwave:

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!! :giggle:

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

Problem Solver
Staff member
Moderator
#3
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?
 
#4
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

Problem Solver
Staff member
Moderator
#5
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.
 
#6
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

Staff member
Super Moderator
#7
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

Involved In Discussions
#8
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.
 
Thread starter Similar threads Forum Replies Date
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Z Do we still have to put UDI if we have DI and lot number seperately on our product ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Requirements relating to Serial Number and Lot Number Other US Medical Device Regulations 6
M Component Lot Number Traceability - Class I reusable and "resposable" Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 10
R Why the FDA requests Lot Number in Testing Reports 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
V FDA regulatory requirement on the lot number convention for medical devices US Food and Drug Administration (FDA) 2
K Can I use ANSI/AQL for the Total Number of Containers for the entire Lot? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Pipet tips of the same Lot Number have different expiration dates Quality Manager and Management Related Issues 6
C Statistics equation to determine the number of samples in a lot Statistical Analysis Tools, Techniques and SPC 8
K Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and number) EU Medical Device Regulations 7
P New Part Traceability - Lot number and finished product traceability ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Design of Lot Acceptance Sampling Plan - Zero Acceptance Number Sampling Plans Inspection, Prints (Drawings), Testing, Sampling and Related Topics 27
A Lot Number Assignment for Incoming Purchased Products and Customer Supplied Material Document Control Systems, Procedures, Forms and Templates 2
shimonv Single lot release for sterile packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Sample size definition in an Automotive SMT pilot lot run Misc. Quality Assurance and Business Systems Related Topics 1
D Supplied Product on Control Plan - Lot ranging in 40,000 pcs per product FMEA and Control Plans 3
K FDA Lot Code format requirements Other Medical Device and Orthopedic Related Topics 1
R Documenting Expiration Date Extension for a specific lot ISO 13485:2016 - Medical Device Quality Management Systems 12
S Lot assignment for secondary reference standard - Pharmaceuticals Manufacturing and Related Processes 0
N AS9100 8.5.1 j) - Lot splitting - any loopholes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
I Lot or Batch definition for IVDs Imported Legacy Blogs 0
N IVD Lot Numbers and Expiration Dates - 21 CFR 809.10 Other US Medical Device Regulations 3
J PMA Device - Lot # change in New ERP Software - What are the FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
V 'Representative' Sample of the Lot for a Continuous Process Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
J Change in Lot Release Specifications - Definition of "Substantial Change" EU Medical Device Regulations 14
M Lot Numbers of Plastic Disposables in an LDT (laboratory developed test) ISO 13485:2016 - Medical Device Quality Management Systems 6
M How to Mathemetically Derive the AQL Tables given Lot Sizes AQL - Acceptable Quality Level 5
D Dual Lot Manufacturing requirements for Clinical Customers Manufacturing and Related Processes 3
E Is Design Transfer to Production be complete prior to Release of first production lot 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Validating a Process Based on Lot Release Criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
U AQL, Lot Size vs Sampling Plans AQL - Acceptable Quality Level 8
Sam Lazzara Lot Release Testing versus Process Validation Studies Qualification and Validation (including 21 CFR Part 11) 9
H How to calculate the Lot Reject Rate Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
A How can a sample can give information about bad products in whole lot? Quality Manager and Management Related Issues 3
L Regulatory Submittal During 3 Lot Sterilization Validation EU Medical Device Regulations 3
P Lot Acceptance Plan that specifies BS 6001 Double Sampling Plans, general inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
N Switch to 100% inspection when lot fails sampling? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
G Calculating the Fraction Defective Confidence Interval for a Lot Statistical Analysis Tools, Techniques and SPC 2
S Samples for a Destructive Test included in a Lot Size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
E How to determine the Lot Size for the OQ Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
Ronen E Matrixx Initiatives Recalls One Lot of Zicam? Extreme Congestion Relief Other Medical Device and Orthopedic Related Topics 0
C Changing the Sample Size of a Lot Statistical Analysis Tools, Techniques and SPC 8
J Expanding the c = 0 Small Lot Squeglia Table Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
R Sampling Plan for Wafer Inspection (Small Lot) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
P Certificate of Free Sales (CFS) - Need to attach to each lot of exported product? Other Medical Device Regulations World-Wide 2
C What's the sampling plan I need to inspect for each lot? AQL - Acceptable Quality Level 7
T Trouble Inputting a lot of Data into Minitab Using Minitab Software 5
R Where does 20% Lot Qualification Rule Come from? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
B Customer Inspection Frequency and Rejection Level Criteria - Sample Lot Size AQL - Acceptable Quality Level 6
A Rationalizing the use Lot Sizes greater than the PQ runs used in Process Validations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3

Similar threads

Top Bottom