Regulatory Open Forum

Dear all,

Please advise . Do we need to change the UDI number when we have a significant change like new sterilization method.
If yes, how should I proceed?
if no, in which case the UDI number could change?

Thank you for your help.
Rgds

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

​Hi Nadine,
Please find under the following link a Q&A recently published on the topic of UDI, which might help you:
https://ec.europa.eu/docsroom/documents/42641?locale=en

11. What changes in the medical device would require a new UDI-DI?

A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability. In particular, a new UDI-DI shall be required in the case of any change of the following elements: name or trade name, device version or model, labelled as single use, packaged sterile, need for sterilisation before use, quantity of devices provided in a package, critical warnings or contra-indications and CMR/Endocrine disruptors.

A UDI-DI shall be associated with one and only one Basic UDI-DI.

Additional information on this aspect is available at MDCG 2018-1 v3 guidance document.

Kind regards,
Anna-Sophie

------------------------------
Anna-Sophie Geiersberger
Unterschleissheim
Germany
------------------------------

Original Message:
Sent: 13-Aug-2020 12:34
From: Nadine Adia
Subject: Change of UDI number

Dear all,

Please advise . Do we need to change the UDI number when we have a significant change like new sterilization method.
If yes, how should I proceed?
if no, in which case the UDI number could change?

Thank you for your help.
Rgds

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------
​

Hi Nadine,

In my view change of sterilisation would not require a change or assignment of UDI number.  Typically a new UDI number would be needed when there is a change affecting the packaging such as the direct device label, packaging configuration, or unit of measure.  This could also be changes to the actual device where even though a new part number would not be assigned if the product was significantly different such as change in material - the "identity" of the product might be considered different.  I would not see a change in sterilisation as affecting the identity or traceability of the device.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 14-Aug-2020 03:14
From: Anna-Sophie Geiersberger
Subject: Change of UDI number

​Hi Nadine,
Please find under the following link a Q&A recently published on the topic of UDI, which might help you:
https://ec.europa.eu/docsroom/documents/42641?locale=en

11. What changes in the medical device would require a new UDI-DI?

A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability. In particular, a new UDI-DI shall be required in the case of any change of the following elements: name or trade name, device version or model, labelled as single use, packaged sterile, need for sterilisation before use, quantity of devices provided in a package, critical warnings or contra-indications and CMR/Endocrine disruptors.

A UDI-DI shall be associated with one and only one Basic UDI-DI.

Additional information on this aspect is available at MDCG 2018-1 v3 guidance document.

Kind regards,
Anna-Sophie

------------------------------
Anna-Sophie Geiersberger
Unterschleissheim
Germany

Original Message:
Sent: 13-Aug-2020 12:34
From: Nadine Adia
Subject: Change of UDI number

Dear all,

Please advise . Do we need to change the UDI number when we have a significant change like new sterilization method.
If yes, how should I proceed?
if no, in which case the UDI number could change?

Thank you for your help.
Rgds

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------
​

As a general rule, I change the UDI whenever

1) you change something that impacts the data in the GUDID database, or
2) when you significantly change the device design

In this case, changing the sterilization method hits #1, so you should use a new UDI for the changed device. Note that in reality, because of new questions raised with changed sterilization methods, it falls under #2 as well....

Obviously, it can be more complex than this, but it works as a "rule of thumb" that is easy to teach the rest of the organization.

g-
​​

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 13-Aug-2020 12:34
From: Nadine Adia
Subject: Change of UDI number

Dear all,

Please advise . Do we need to change the UDI number when we have a significant change like new sterilization method.
If yes, how should I proceed?
if no, in which case the UDI number could change?

Thank you for your help.
Rgds

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

I infer you are asking about the US system. There are two requirements for a new UDI-DI: the change affects the version or model or the change affects certain entries in GUDID.

If you need a new UDI-DI, then change the device label and all the packaging configuration labels. Modify the existing GUDID record to show the device and packaging discontinue dates. Create a new GUDID record for the new UDI-DI.

Under 830.50 if you make a change to a device and the change results in a new version or model, you must assign a new device identifier to the new version or model.

830.3 defines a version or model as all devices that have specifications, performance, size, and composition, within limits set by the labeler. The presumption is that you have determined the limits before the design change and evaluate them after to change to determine the need for a new UDI-DI.

I also generally think of this as from the customer's point of view. If they would consider the device different in some way, then it is a new version or model and needs a new UDI-DI.

The second case is the GUDID attributes.

The attribute "Device Packaged as Sterile", is Yes/No, but doesn't include the sterilization method. Presumably, your response is Yes and the device change will not change this attribute.

Another consideration is the 510(k) change analysis which includes, "For instance, a change in sterilization that may unintentionally affect device performance should be reviewed as a sterilization change under B3 and as a performance specification change under B5".

Review the questions and you response, because some combinations can lead to a performance change that creates a new version of model and requires a new UDI-DI.

The following combinations of answers require a new 510(k):
B3 = Yes & B3.1 = Yes
B3 = Yes, B3.1 = No, & B3.2 = Yes

B3. Is it a change in sterilization, cleaning, or disinfection?

B3.1 Is it a change to an "established category B" or "novel" sterilization method, does the change lower the sterility assurance level, or is it a change to how the device is provided?

B3.2 Could the change significantly affect the performance or biocompatibility of the device?

The following combinations of answers require a new 510(k):
B5 = Yes & (B5.1 = Yes OR B5.2 = Yes OR B5.3 = Yes OR B5.4 = Yes)

B5. Is it any other change in design (e.g., dimensions, performance specifications, wireless communication, components or accessories, or the patient/user interface)?

B5.1 Does the change significantly affect the use of the device?

B5.2 Does a risk-based assessment of the changed device identify any new risks or significantly modified existing risks?

B5.3 Are clinical data necessary to evaluate safety or effectiveness for purposes of design validation?

B5.4 Do design verification and/or validation activities produce any unexpected issues of safety or effectiveness?

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 13-Aug-2020 12:34
From: Nadine Adia
Subject: Change of UDI number

Dear all,

Please advise . Do we need to change the UDI number when we have a significant change like new sterilization method.
If yes, how should I proceed?
if no, in which case the UDI number could change?

Thank you for your help.
Rgds

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Thank you all very much for your relevant answers, I have taken careful note.

If I understand well, when change affect the label (significant change) like a product which was not sold sterile but now it's, then I have to get a new UDI . 

However, regarding the change in the sterilization method( product was already sterilized and we have change the method) I done the exercise on change something that impacts the data in the GUDID database and yes this information will change and yes it's required a new 510K but this change does not affect the label.

UDI= UDI-DI +UDI-PI

Basis UDI-DI is it different from UDI-DI?
Rgds,
​

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Original Message:
Sent: 13-Aug-2020 12:34
From: Nadine Adia
Subject: Change of UDI number

Dear all,

Please advise . Do we need to change the UDI number when we have a significant change like new sterilization method.
If yes, how should I proceed?
if no, in which case the UDI number could change?

Thank you for your help.
Rgds

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

GUDID does not include the sterilization method, so that information will not change. It only asks whether the device is delivered sterile Yes/No.

It used to be (I think) that a new 510(k) number required a new UDI-DI. When I checked this morning, it is not a trigger for a new UDI-DI. However, in my opinion, it would be a rare case in which a change that requires a new 510(k) does not change the version or model under the UDI rule.

You are right that UDI = UDI-DI + UDI-PI. However, the only concern, in this case, is the UDI-DI, since it represents the manufacturer and the version or model.

I infer that for Basis UDI-DI you mean Basic UDI-DI. This is an EU only concept. The Basic UDI-DI represents a device family with similar characteristics. In the EU system, a device change could require a new UDI-DI, but the change doesn't affect the device family, so the Basic UDI-DI would not change.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 14-Aug-2020 11:02
From: Nadine Adia
Subject: Change of UDI number

Thank you all very much for your relevant answers, I have taken careful note.

If I understand well, when change affect the label (significant change) like a product which was not sold sterile but now it's, then I have to get a new UDI .

However, regarding the change in the sterilization method( product was already sterilized and we have change the method) I done the exercise on change something that impacts the data in the GUDID database and yes this information will change and yes it's required a new 510K but this change does not affect the label.

UDI= UDI-DI +UDI-PI

Basis UDI-DI is it different from UDI-DI?
Rgds,
​

------------------------------
Nadine Adia
Quebec QC
Canada

Original Message:
Sent: 13-Aug-2020 12:34
From: Nadine Adia
Subject: Change of UDI number

Dear all,

Please advise . Do we need to change the UDI number when we have a significant change like new sterilization method.
If yes, how should I proceed?
if no, in which case the UDI number could change?

Thank you for your help.
Rgds

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Perfect.
Thank you so much all. it clear.
Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Original Message:
Sent: 14-Aug-2020 11:33
From: Dan O'Leary
Subject: Change of UDI number

GUDID does not include the sterilization method, so that information will not change. It only asks whether the device is delivered sterile Yes/No.

It used to be (I think) that a new 510(k) number required a new UDI-DI. When I checked this morning, it is not a trigger for a new UDI-DI. However, in my opinion, it would be a rare case in which a change that requires a new 510(k) does not change the version or model under the UDI rule.

You are right that UDI = UDI-DI + UDI-PI. However, the only concern, in this case, is the UDI-DI, since it represents the manufacturer and the version or model.

I infer that for Basis UDI-DI you mean Basic UDI-DI. This is an EU only concept. The Basic UDI-DI represents a device family with similar characteristics. In the EU system, a device change could require a new UDI-DI, but the change doesn't affect the device family, so the Basic UDI-DI would not change.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 14-Aug-2020 11:02
From: Nadine Adia
Subject: Change of UDI number

Thank you all very much for your relevant answers, I have taken careful note.

If I understand well, when change affect the label (significant change) like a product which was not sold sterile but now it's, then I have to get a new UDI .

However, regarding the change in the sterilization method( product was already sterilized and we have change the method) I done the exercise on change something that impacts the data in the GUDID database and yes this information will change and yes it's required a new 510K but this change does not affect the label.

UDI= UDI-DI +UDI-PI

Basis UDI-DI is it different from UDI-DI?
Rgds,
​

------------------------------
Nadine Adia
Quebec QC
Canada

Original Message:
Sent: 13-Aug-2020 12:34
From: Nadine Adia
Subject: Change of UDI number

Dear all,

Please advise . Do we need to change the UDI number when we have a significant change like new sterilization method.
If yes, how should I proceed?
if no, in which case the UDI number could change?

Thank you for your help.
Rgds

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------