Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello RAPS,

We have a new-generation (software updates) Class II device currently cleared in the US, but not in the EU. The hardware parts and labels have the same part numbers for both generations, and they have the CE Mark and AR information on them. We are reworking to overlabel the CE Mark, and I am saying that we need to overlabel the AR address as well. There is some pushback, as we are nearing commercialization, so I am looking for some evidence to back me up, or prove me wrong. Would this constitute as mislabeling as the new generation is not cleared in the EU yet?

Hello Anon,

Whatever products are placed on the market in the EU need to be compliant with all of the regulations.  If you distribute products in the EU as an entity outside without identifying the Authorised Representative than indeed it would be mis-labelled.  This is a requirement under the MDD, IVDD, EU MDR, and EU IVDR.  If you get push-back just cite the Directive and Regulation where identification of the AR is required.

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

Original Message:
Sent: 09-Jul-2021 14:05
From: Anonymous Member
Subject: Authorized Rep on label

This message was posted by a user wishing to remain anonymous

Hello RAPS,

We have a new-generation (software updates) Class II device currently cleared in the US, but not in the EU. The hardware parts and labels have the same part numbers for both generations, and they have the CE Mark and AR information on them. We are reworking to overlabel the CE Mark, and I am saying that we need to overlabel the AR address as well. There is some pushback, as we are nearing commercialization, so I am looking for some evidence to back me up, or prove me wrong. Would this constitute as mislabeling as the new generation is not cleared in the EU yet?

Original Message:
Sent: 7/11/2021 2:12:00 AM
From: Richard Vincins
Subject: RE: Authorized Rep on label

Hello Anon,

Whatever products are placed on the market in the EU need to be compliant with all of the regulations.  If you distribute products in the EU as an entity outside without identifying the Authorised Representative than indeed it would be mis-labelled.  This is a requirement under the MDD, IVDD, EU MDR, and EU IVDR.  If you get push-back just cite the Directive and Regulation where identification of the AR is required.

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

Original Message:
Sent: 09-Jul-2021 14:05
From: Anonymous Member
Subject: Authorized Rep on label

This message was posted by a user wishing to remain anonymous

Hello RAPS,

We have a new-generation (software updates) Class II device currently cleared in the US, but not in the EU. The hardware parts and labels have the same part numbers for both generations, and they have the CE Mark and AR information on them. We are reworking to overlabel the CE Mark, and I am saying that we need to overlabel the AR address as well. There is some pushback, as we are nearing commercialization, so I am looking for some evidence to back me up, or prove me wrong. Would this constitute as mislabeling as the new generation is not cleared in the EU yet?

This message was posted by a user wishing to remain anonymous

Hi Naomi,

Thank you for your reply; your interpretation is correct. The launch is US only, and I am worried that having the AR info will be seen as the device being cleared for sale in the EU when it is not.
Original Message:
Sent: 12-Jul-2021 09:19
From: Naomi Halpern
Subject: Authorized Rep on label

Could you clarify?  Are you asking whether the product that you put on the market in the US would be misbranded in the US due to the presence of the address of the European Authorized Representative because you are not actually marketing in Europe until you have clearance there? 

 

Naomi J. L. Halpern

Commercial Counsel

100 Technology Center Drive | Suite 300

Stoughton, MA 02072

Main:  781-713-3699 | Direct: 781-573-3941 | Mobile: 301-807-2574

nhalpern@collegiumpharma.com

pronouns: she/her(s)

 

 

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Original Message:
Sent: 7/11/2021 2:12:00 AM
From: Richard Vincins
Subject: RE: Authorized Rep on label

Hello Anon,

Whatever products are placed on the market in the EU need to be compliant with all of the regulations.  If you distribute products in the EU as an entity outside without identifying the Authorised Representative than indeed it would be mis-labelled.  This is a requirement under the MDD, IVDD, EU MDR, and EU IVDR.  If you get push-back just cite the Directive and Regulation where identification of the AR is required.

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

Original Message:
Sent: 09-Jul-2021 14:05
From: Anonymous Member
Subject: Authorized Rep on label

This message was posted by a user wishing to remain anonymous

Hello RAPS,

We have a new-generation (software updates) Class II device currently cleared in the US, but not in the EU. The hardware parts and labels have the same part numbers for both generations, and they have the CE Mark and AR information on them. We are reworking to overlabel the CE Mark, and I am saying that we need to overlabel the AR address as well. There is some pushback, as we are nearing commercialization, so I am looking for some evidence to back me up, or prove me wrong. Would this constitute as mislabeling as the new generation is not cleared in the EU yet?

This message was posted by a user wishing to remain anonymous

Hi Richard,

Thank you for your reply - I should have been more clear in the question - the launch is currently US only.

A couple of factors here to include with the commercialization aspect are - I recently joined, so I haven't had time to build relationships and trust yet, and I am not high on the hierarchy as well, so my voice does not have too much power.
Original Message:
Sent: 11-Jul-2021 02:12
From: Richard Vincins
Subject: Authorized Rep on label

Hello Anon,

Whatever products are placed on the market in the EU need to be compliant with all of the regulations.  If you distribute products in the EU as an entity outside without identifying the Authorised Representative than indeed it would be mis-labelled.  This is a requirement under the MDD, IVDD, EU MDR, and EU IVDR.  If you get push-back just cite the Directive and Regulation where identification of the AR is required.

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

Original Message:
Sent: 09-Jul-2021 14:05
From: Anonymous Member
Subject: Authorized Rep on label

This message was posted by a user wishing to remain anonymous

Hello RAPS,

We have a new-generation (software updates) Class II device currently cleared in the US, but not in the EU. The hardware parts and labels have the same part numbers for both generations, and they have the CE Mark and AR information on them. We are reworking to overlabel the CE Mark, and I am saying that we need to overlabel the AR address as well. There is some pushback, as we are nearing commercialization, so I am looking for some evidence to back me up, or prove me wrong. Would this constitute as mislabeling as the new generation is not cleared in the EU yet?

This message was posted by a user wishing to remain anonymous

Please correct me if I am wrong, 
it seems to me like a system HW+SW. While the HW didn't change, the SW did. I don't understand why you need to relabel your HW device at all while you deploy the new SW (which obviously won't be marketed in the EU).
Please note that if you provide SW as part of the system, you probably have the SW version, and you indicate the CE mark in the SW. If that is the case, you may consider removing the CE from the SW component for the US deployment.  
Anyway, if you are still going ahead and removing the marking, I suspect that CE and AR go hand in hand. 


Original Message:
Sent: 09-Jul-2021 14:05
From: Anonymous Member
Subject: Authorized Rep on label

This message was posted by a user wishing to remain anonymous

Hello RAPS,

We have a new-generation (software updates) Class II device currently cleared in the US, but not in the EU. The hardware parts and labels have the same part numbers for both generations, and they have the CE Mark and AR information on them. We are reworking to overlabel the CE Mark, and I am saying that we need to overlabel the AR address as well. There is some pushback, as we are nearing commercialization, so I am looking for some evidence to back me up, or prove me wrong. Would this constitute as mislabeling as the new generation is not cleared in the EU yet?

This message was posted by a user wishing to remain anonymous

​Is there any chance this device might be carried into Europe?  A properly designated EC REP is legally liable for defective devices, so if something happened to go wrong, they might be unhappy.

If this version is different enough to need new clearances, it probably has a different UDI, yes?

From a practical perspective, it's sometimes easiest to have all such info on one ID label, with one review process. Depending on device size and shape, though, the info may be scattered in different places, with nameplates, adhesive labels, silkscreens, and what-have-you. Definitely challenging to manage for compliance.
Original Message:
Sent: 09-Jul-2021 14:05
From: Anonymous Member
Subject: Authorized Rep on label

This message was posted by a user wishing to remain anonymous

Hello RAPS,

We have a new-generation (software updates) Class II device currently cleared in the US, but not in the EU. The hardware parts and labels have the same part numbers for both generations, and they have the CE Mark and AR information on them. We are reworking to overlabel the CE Mark, and I am saying that we need to overlabel the AR address as well. There is some pushback, as we are nearing commercialization, so I am looking for some evidence to back me up, or prove me wrong. Would this constitute as mislabeling as the new generation is not cleared in the EU yet?

This message was posted by a user wishing to remain anonymous

Hello Anon,

It certainly is desirable for all the info to be on one label, but the device is large enough to require different labeling materials.
To answer your question, the chances of it getting carried into Europe are largely negligible.
Original Message:
Sent: 10-Jul-2021 16:26
From: Anonymous Member
Subject: Authorized Rep on label

This message was posted by a user wishing to remain anonymous

​Is there any chance this device might be carried into Europe?  A properly designated EC REP is legally liable for defective devices, so if something happened to go wrong, they might be unhappy.

If this version is different enough to need new clearances, it probably has a different UDI, yes?

From a practical perspective, it's sometimes easiest to have all such info on one ID label, with one review process. Depending on device size and shape, though, the info may be scattered in different places, with nameplates, adhesive labels, silkscreens, and what-have-you. Definitely challenging to manage for compliance.
Original Message:
Sent: 09-Jul-2021 14:05
From: Anonymous Member
Subject: Authorized Rep on label

This message was posted by a user wishing to remain anonymous

Hello RAPS,

We have a new-generation (software updates) Class II device currently cleared in the US, but not in the EU. The hardware parts and labels have the same part numbers for both generations, and they have the CE Mark and AR information on them. We are reworking to overlabel the CE Mark, and I am saying that we need to overlabel the AR address as well. There is some pushback, as we are nearing commercialization, so I am looking for some evidence to back me up, or prove me wrong. Would this constitute as mislabeling as the new generation is not cleared in the EU yet?

Hi Anon, I would consider leaving the AR without the CE mark as a RA oversight or a 'sloppy typo' and I would insist on fixing it ASAP, but if your team is too close to commercialization, I would ask how soon it will be fixed after the fact, and what is the impact on implementing the change after launching the product.

------------------------------
Yelena Girshman
Regulatory Affairs Specialist
Sunnyvale CA
United States
------------------------------

Original Message:
Sent: 12-Jul-2021 19:39
From: Anonymous Member
Subject: Authorized Rep on label

This message was posted by a user wishing to remain anonymous

Hello Anon,

It certainly is desirable for all the info to be on one label, but the device is large enough to require different labeling materials.
To answer your question, the chances of it getting carried into Europe are largely negligible.
Original Message:
Sent: 10-Jul-2021 16:26
From: Anonymous Member
Subject: Authorized Rep on label

This message was posted by a user wishing to remain anonymous

​Is there any chance this device might be carried into Europe?  A properly designated EC REP is legally liable for defective devices, so if something happened to go wrong, they might be unhappy.

If this version is different enough to need new clearances, it probably has a different UDI, yes?

From a practical perspective, it's sometimes easiest to have all such info on one ID label, with one review process. Depending on device size and shape, though, the info may be scattered in different places, with nameplates, adhesive labels, silkscreens, and what-have-you. Definitely challenging to manage for compliance.
Original Message:
Sent: 09-Jul-2021 14:05
From: Anonymous Member
Subject: Authorized Rep on label

This message was posted by a user wishing to remain anonymous

Hello RAPS,

We have a new-generation (software updates) Class II device currently cleared in the US, but not in the EU. The hardware parts and labels have the same part numbers for both generations, and they have the CE Mark and AR information on them. We are reworking to overlabel the CE Mark, and I am saying that we need to overlabel the AR address as well. There is some pushback, as we are nearing commercialization, so I am looking for some evidence to back me up, or prove me wrong. Would this constitute as mislabeling as the new generation is not cleared in the EU yet?