Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

This is a question relating to Australian medical devices regulations. Are sponsors allowed to re-work a CE mark medical device i.e. open a medical device packaging to remove a global IFU and replace it with an Australian specific CE mark or would this be considered voiding the CE marking?
For this particular product the sterile barrier would not be broken as the IFU sits on top of further inner packaging. However the product is CE marked in its original outer packaging.
Would a sponsor be considered to be a manufacturer and therefore need a manufacturing licence from TGA in order to perform the task described above? Where in the regulations can I find this information?  

Many thanks and kind regards.

Without seeing the actual packaging configuration, it might be construed as not allowed if the original CE Mark of the entire device is not the same.  Meaning if you are replacing the IFU with a CE Mark, but there is still a CE Mark on the outer packaging, this probably would not be allowed.  Though to be honest, this is more a legal type question that you should discuss with the original Notified Body who CE Marked the finished device.  It would really be up to them to determine whether the repackaging/relabeling of the device would void the CE Certificate.  Off the top of my head, it does not sound right or would be properly done.  If the local company is replacing the CE Mark with their own CE mark, then most likely they would now be considered the manufacturer and need all the proper documentation in place as the legal manufacturer.  I am not sure the TGA regulations are this specific, as there is text about who is the manufacturer, but there would be a bit of interpretation in your specific case would have to be done.  Again more, I think you need discussion with the Notified Body placing the original CE Mark as they would/should give the best course of action since it would be that CE Certificate validity being affected.

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

Original Message:
Sent: 19-Feb-2020 00:05
From: Anonymous Member
Subject: Reworking CE marked product in Australia

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

This is a question relating to Australian medical devices regulations. Are sponsors allowed to re-work a CE mark medical device i.e. open a medical device packaging to remove a global IFU and replace it with an Australian specific CE mark or would this be considered voiding the CE marking?
For this particular product the sterile barrier would not be broken as the IFU sits on top of further inner packaging. However the product is CE marked in its original outer packaging.
Would a sponsor be considered to be a manufacturer and therefore need a manufacturing licence from TGA in order to perform the task described above? Where in the regulations can I find this information?

Many thanks and kind regards.

This message was posted by a user wishing to remain anonymous

Thank you RIchard. Apologies, I have an error in my question. What I mean is the IFU will be an Australian specific IFU. Is it possible to open the packacing, remove the global IFU and replace it with an AU IFU? I think you are correct that this would indeed not be allowed.
Original Message:
Sent: 20-Feb-2020 04:59
From: Richard Vincins
Subject: Reworking CE marked product in Australia

Without seeing the actual packaging configuration, it might be construed as not allowed if the original CE Mark of the entire device is not the same.  Meaning if you are replacing the IFU with a CE Mark, but there is still a CE Mark on the outer packaging, this probably would not be allowed.  Though to be honest, this is more a legal type question that you should discuss with the original Notified Body who CE Marked the finished device.  It would really be up to them to determine whether the repackaging/relabeling of the device would void the CE Certificate.  Off the top of my head, it does not sound right or would be properly done.  If the local company is replacing the CE Mark with their own CE mark, then most likely they would now be considered the manufacturer and need all the proper documentation in place as the legal manufacturer.  I am not sure the TGA regulations are this specific, as there is text about who is the manufacturer, but there would be a bit of interpretation in your specific case would have to be done.  Again more, I think you need discussion with the Notified Body placing the original CE Mark as they would/should give the best course of action since it would be that CE Certificate validity being affected.

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

Original Message:
Sent: 19-Feb-2020 00:05
From: Anonymous Member
Subject: Reworking CE marked product in Australia

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

This is a question relating to Australian medical devices regulations. Are sponsors allowed to re-work a CE mark medical device i.e. open a medical device packaging to remove a global IFU and replace it with an Australian specific CE mark or would this be considered voiding the CE marking?
For this particular product the sterile barrier would not be broken as the IFU sits on top of further inner packaging. However the product is CE marked in its original outer packaging.
Would a sponsor be considered to be a manufacturer and therefore need a manufacturing licence from TGA in order to perform the task described above? Where in the regulations can I find this information?

Many thanks and kind regards.

The EU-MDR Article 16 No. 2 provide some guidance which should be considered here:

.... the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:
(a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State;
(b) changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging. 5.5.2017 L 117/29 Official Journal of the European Union

For me this gives a hint that the activities you mentioned are inline with the CE marking as long as you provide the original information of the manufacturer and the "original condition" of the device is not affected.
​
Anyhow this is the view of the EU-MDR it is more important how the TGA sees such activities - maybe your Australian representative can evaluate it.

BR
Frank

------------------------------
Frank Wilmerstaedt
General Manager QA/RA
Hamburg, Germany
------------------------------

Original Message:
Sent: 19-Feb-2020 00:05
From: Anonymous Member
Subject: Reworking CE marked product in Australia

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

This is a question relating to Australian medical devices regulations. Are sponsors allowed to re-work a CE mark medical device i.e. open a medical device packaging to remove a global IFU and replace it with an Australian specific CE mark or would this be considered voiding the CE marking?
For this particular product the sterile barrier would not be broken as the IFU sits on top of further inner packaging. However the product is CE marked in its original outer packaging.
Would a sponsor be considered to be a manufacturer and therefore need a manufacturing licence from TGA in order to perform the task described above? Where in the regulations can I find this information?

Many thanks and kind regards.

This message was posted by a user wishing to remain anonymous

This is really helpful. Thank you Frank!
Original Message:
Sent: 20-Feb-2020 06:17
From: Frank Wilmerstaedt
Subject: Reworking CE marked product in Australia

The EU-MDR Article 16 No. 2 provide some guidance which should be considered here:

.... the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:
(a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State;
(b) changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging. 5.5.2017 L 117/29 Official Journal of the European Union

For me this gives a hint that the activities you mentioned are inline with the CE marking as long as you provide the original information of the manufacturer and the "original condition" of the device is not affected.
​
Anyhow this is the view of the EU-MDR it is more important how the TGA sees such activities - maybe your Australian representative can evaluate it.

BR
Frank

------------------------------
Frank Wilmerstaedt
General Manager QA/RA
Hamburg, Germany

Original Message:
Sent: 19-Feb-2020 00:05
From: Anonymous Member
Subject: Reworking CE marked product in Australia

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

This is a question relating to Australian medical devices regulations. Are sponsors allowed to re-work a CE mark medical device i.e. open a medical device packaging to remove a global IFU and replace it with an Australian specific CE mark or would this be considered voiding the CE marking?
For this particular product the sterile barrier would not be broken as the IFU sits on top of further inner packaging. However the product is CE marked in its original outer packaging.
Would a sponsor be considered to be a manufacturer and therefore need a manufacturing licence from TGA in order to perform the task described above? Where in the regulations can I find this information?

Many thanks and kind regards.

Please clarify what do you mean by "Australian specific CE mark". TGA under the MRA can act as a NB for local Australian manufacturers only and not for overseas manufacturers. For overseas manufacturer, the TGA does conformity assessment (similar process to CE marking) and provides TGA specific conformity assessment certificate.

------------------------------
Romit Singh, MBA, RAC
Pre Market Team Leader
Belrose
Australia
------------------------------

Original Message:
Sent: 19-Feb-2020 00:05
From: Anonymous Member
Subject: Reworking CE marked product in Australia

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

This is a question relating to Australian medical devices regulations. Are sponsors allowed to re-work a CE mark medical device i.e. open a medical device packaging to remove a global IFU and replace it with an Australian specific CE mark or would this be considered voiding the CE marking?
For this particular product the sterile barrier would not be broken as the IFU sits on top of further inner packaging. However the product is CE marked in its original outer packaging.
Would a sponsor be considered to be a manufacturer and therefore need a manufacturing licence from TGA in order to perform the task described above? Where in the regulations can I find this information?

Many thanks and kind regards.

This message was posted by a user wishing to remain anonymous

Thank you Romit. I meant to say Australian specific IFU. Apologies for the confusion.
Original Message:
Sent: 24-Feb-2020 21:16
From: Romit Singh, MBA, RAC
Subject: Reworking CE marked product in Australia

Please clarify what do you mean by "Australian specific CE mark". TGA under the MRA can act as a NB for local Australian manufacturers only and not for overseas manufacturers. For overseas manufacturer, the TGA does conformity assessment (similar process to CE marking) and provides TGA specific conformity assessment certificate.

------------------------------
Romit Singh, MBA, RAC
Pre Market Team Leader
Belrose
Australia

Original Message:
Sent: 19-Feb-2020 00:05
From: Anonymous Member
Subject: Reworking CE marked product in Australia

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

This is a question relating to Australian medical devices regulations. Are sponsors allowed to re-work a CE mark medical device i.e. open a medical device packaging to remove a global IFU and replace it with an Australian specific CE mark or would this be considered voiding the CE marking?
For this particular product the sterile barrier would not be broken as the IFU sits on top of further inner packaging. However the product is CE marked in its original outer packaging.
Would a sponsor be considered to be a manufacturer and therefore need a manufacturing licence from TGA in order to perform the task described above? Where in the regulations can I find this information?

Many thanks and kind regards.