Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello everyone,
Would like to hear your thoughts on the following. We have received FDA clearance for a device which is currently also under review for MDR CE mark. The product has same label in US and EU and the CE mark appears on the label. My question here is can you sell your device in U.S once you have received your FDA clearance if your device has the CE mark symbol and CE mark is not yet granted? I know that CE mark produces effects only in the EU, however I believe it would be misleading to put on US marked a product which apparently states it is CE marked. Do you agree?
Many thanks to you all,

Good afternoon, It is obviously not a good idea to include inaccurate information on labeling. From FDA perspective, I think they would consider an erroneous CE mark as misleading per 21 CFR 801.6. Furthermore, FDA expects labeling, including promotional material, to be truthful. 

As far as CE mark, per 2017/745 Article 20 the NB identification is included with the CE mark, presumably after they completed their conformity assessment. Since you won't have your conformity assessment done, it would be inappropriate to include the NB identification number making any CE mark incomplete. EU would likely consider your device a falsified device per definition in Article 2.

------------------------------
Adam Atherton
Farragut TN
United States
------------------------------

Original Message:
Sent: 10-Apr-2020 09:55
From: Anonymous Member
Subject: CE mark effect in U.S

This message was posted by a user wishing to remain anonymous

Hello everyone,
Would like to hear your thoughts on the following. We have received FDA clearance for a device which is currently also under review for MDR CE mark. The product has same label in US and EU and the CE mark appears on the label. My question here is can you sell your device in U.S once you have received your FDA clearance if your device has the CE mark symbol and CE mark is not yet granted? I know that CE mark produces effects only in the EU, however I believe it would be misleading to put on US marked a product which apparently states it is CE marked. Do you agree?
Many thanks to you all,

Regardless of where in the world you are selling the device, including the CE Mark on the label is declaring the device conforms to the Directive/Regulation.  As you say this is under review by a Notified Body the CE Mark with Notified Body number should not be on the label until you obtain the EC Certificate.  Selling the product in the US with a CE Mark does not necessarily go against U.S. law - though some would view as mis-branding - if your Notified Body understood or found out you already had product in the field with CE Mark on the label, that is a completely different set of problems.  And not ones I would want to try and answer.  So in answer to your question, yes it would be misleading.

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

Original Message:
Sent: 10-Apr-2020 13:54
From: Adam Atherton
Subject: CE mark effect in U.S

Good afternoon, It is obviously not a good idea to include inaccurate information on labeling. From FDA perspective, I think they would consider an erroneous CE mark as misleading per 21 CFR 801.6. Furthermore, FDA expects labeling, including promotional material, to be truthful.

As far as CE mark, per 2017/745 Article 20 the NB identification is included with the CE mark, presumably after they completed their conformity assessment. Since you won't have your conformity assessment done, it would be inappropriate to include the NB identification number making any CE mark incomplete. EU would likely consider your device a falsified device per definition in Article 2.

------------------------------
Adam Atherton
Farragut TN
United States

Original Message:
Sent: 10-Apr-2020 09:55
From: Anonymous Member
Subject: CE mark effect in U.S

This message was posted by a user wishing to remain anonymous

Hello everyone,
Would like to hear your thoughts on the following. We have received FDA clearance for a device which is currently also under review for MDR CE mark. The product has same label in US and EU and the CE mark appears on the label. My question here is can you sell your device in U.S once you have received your FDA clearance if your device has the CE mark symbol and CE mark is not yet granted? I know that CE mark produces effects only in the EU, however I believe it would be misleading to put on US marked a product which apparently states it is CE marked. Do you agree?
Many thanks to you all,

I agree with Adam and Richard.  A possible solution is to have a top level finished part number for US and a different top level finished part number for EU.  The only difference is the labeling.

------------------------------
Michael Schnabel CQE, MBA
Sr. Director Quality and Regulatory
Chaska MN
United States
------------------------------

Original Message:
Sent: 10-Apr-2020 09:55
From: Anonymous Member
Subject: CE mark effect in U.S

This message was posted by a user wishing to remain anonymous

Hello everyone,
Would like to hear your thoughts on the following. We have received FDA clearance for a device which is currently also under review for MDR CE mark. The product has same label in US and EU and the CE mark appears on the label. My question here is can you sell your device in U.S once you have received your FDA clearance if your device has the CE mark symbol and CE mark is not yet granted? I know that CE mark produces effects only in the EU, however I believe it would be misleading to put on US marked a product which apparently states it is CE marked. Do you agree?
Many thanks to you all,

Yes. I have discussed this with the NB and it is ok. As long as there are controls in place to prevent the device from being shipped to the EU until it's approved. No need for multiple SKUs/ZFIN. One label with FDA and CE is ok. Also the organization will thank you as well.

------------------------------
Kellie Stefaniak
Sr. Director Regulatory Affairs
Salt Lake City UT
United States
------------------------------

Original Message:
Sent: 12-Apr-2020 10:44
From: Michael Schnabel
Subject: CE mark effect in U.S

I agree with Adam and Richard.  A possible solution is to have a top level finished part number for US and a different top level finished part number for EU.  The only difference is the labeling.

------------------------------
Michael Schnabel CQE, MBA
Sr. Director Quality and Regulatory
Chaska MN
United States

Original Message:
Sent: 10-Apr-2020 09:55
From: Anonymous Member
Subject: CE mark effect in U.S

This message was posted by a user wishing to remain anonymous

Hello everyone,
Would like to hear your thoughts on the following. We have received FDA clearance for a device which is currently also under review for MDR CE mark. The product has same label in US and EU and the CE mark appears on the label. My question here is can you sell your device in U.S once you have received your FDA clearance if your device has the CE mark symbol and CE mark is not yet granted? I know that CE mark produces effects only in the EU, however I believe it would be misleading to put on US marked a product which apparently states it is CE marked. Do you agree?
Many thanks to you all,

Short answer just don't!
The CE Mark is applied based on a declaration of conformity made by you or your EUAR.
If you know that there is no such valid declaration based on a completed conformity assessment route, but still allow the CE to be applied, it is fraudulently applied.
A criminal offense has most likely been committed in the Manufacturers or EUAR's EU Member State.
Last year a company director was jailed for fraud in the UK.
Last year Notified Bodies prosecuted their customers for applying their numbers incorrectly.
... and just wait till your distributors' lawyers get a whiff of the size of civil damages they might receive!
Take the CE Mark seriously, if it not legal: brand it out, permanently obscure it with a tamper proof label or something similar.
... and if the declaration is under MDR - remember you now have the PRRC and EUAR to answer for the criminal and civil penalties.
Just Don't!

Neil

------------------------------
Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom
------------------------------

Original Message:
Sent: 10-Apr-2020 09:55
From: Anonymous Member
Subject: CE mark effect in U.S

This message was posted by a user wishing to remain anonymous

Hello everyone,
Would like to hear your thoughts on the following. We have received FDA clearance for a device which is currently also under review for MDR CE mark. The product has same label in US and EU and the CE mark appears on the label. My question here is can you sell your device in U.S once you have received your FDA clearance if your device has the CE mark symbol and CE mark is not yet granted? I know that CE mark produces effects only in the EU, however I believe it would be misleading to put on US marked a product which apparently states it is CE marked. Do you agree?
Many thanks to you all,

If it was fraud in the UK, then the UK must have recognized the CE Mark for market access.  FDA does not. Besides, in the US, you only end up in jail for fraud if you stiff CMS. (That is sort of a joke.)

In the US, only the government can prosecute; all others must sue.  If the NBs sued their customers for apply numbers incorrectly, I'm wondering if that was under the regulations, or per their contractual agreement with their customers.  I've always been under the impression that the NBs have no legal enforcement authority.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 13-Apr-2020 05:47
From: Neil Armstrong
Subject: CE mark effect in U.S

Short answer just don't!
The CE Mark is applied based on a declaration of conformity made by you or your EUAR.
If you know that there is no such valid declaration based on a completed conformity assessment route, but still allow the CE to be applied, it is fraudulently applied.
A criminal offense has most likely been committed in the Manufacturers or EUAR's EU Member State.
Last year a company director was jailed for fraud in the UK.
Last year Notified Bodies prosecuted their customers for applying their numbers incorrectly.
... and just wait till your distributors' lawyers get a whiff of the size of civil damages they might receive!
Take the CE Mark seriously, if it not legal: brand it out, permanently obscure it with a tamper proof label or something similar.
... and if the declaration is under MDR - remember you now have the PRRC and EUAR to answer for the criminal and civil penalties.
Just Don't!

Neil

------------------------------
Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom

Original Message:
Sent: 10-Apr-2020 09:55
From: Anonymous Member
Subject: CE mark effect in U.S

This message was posted by a user wishing to remain anonymous

Hello everyone,
Would like to hear your thoughts on the following. We have received FDA clearance for a device which is currently also under review for MDR CE mark. The product has same label in US and EU and the CE mark appears on the label. My question here is can you sell your device in U.S once you have received your FDA clearance if your device has the CE mark symbol and CE mark is not yet granted? I know that CE mark produces effects only in the EU, however I believe it would be misleading to put on US marked a product which apparently states it is CE marked. Do you agree?
Many thanks to you all,

Hi Julie:
Sorry, I was not meaning to imply there was any extra-jurisdictional reach for a CE Mark, just that if it is applied as stated under the MDR, there must be an EUAR and EUAR's PRRC accepting responsibility in Europe. So if the manufacturer is outside Europe it is the EUAR and their PRRC that may be liable. The difficulty in the days of global trade and travel, if we ever return to them, is wherever the product is put on the market, it can end up in Europe and the onus is then on EUAR.
One of the intentions of the new regulations was to produce a more uniform approach to enforcement and prosecuting across the EU - maybe that is no longer likely in the post-Covid 19 world.
However, I believe there is an ethical concern: the CE mark is seen as a badge of safety and performance on which many people rely, and to put it on without proper sanction is as ethically wrong as sticking on other safety or compliance badge without proper authority ... just in the belief the product should pass. The other point is to remember what the CE signifies, that the product complies with all applicable European Regulations and Directives - it is just plain wrong for an ethical business not to take placing it in a product seriously.

------------------------------
Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom
------------------------------

Original Message:
Sent: 14-Apr-2020 01:30
From: Julie Omohundro
Subject: CE mark effect in U.S

If it was fraud in the UK, then the UK must have recognized the CE Mark for market access.  FDA does not. Besides, in the US, you only end up in jail for fraud if you stiff CMS. (That is sort of a joke.)

In the US, only the government can prosecute; all others must sue.  If the NBs sued their customers for apply numbers incorrectly, I'm wondering if that was under the regulations, or per their contractual agreement with their customers.  I've always been under the impression that the NBs have no legal enforcement authority.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Apr-2020 05:47
From: Neil Armstrong
Subject: CE mark effect in U.S

Short answer just don't!
The CE Mark is applied based on a declaration of conformity made by you or your EUAR.
If you know that there is no such valid declaration based on a completed conformity assessment route, but still allow the CE to be applied, it is fraudulently applied.
A criminal offense has most likely been committed in the Manufacturers or EUAR's EU Member State.
Last year a company director was jailed for fraud in the UK.
Last year Notified Bodies prosecuted their customers for applying their numbers incorrectly.
... and just wait till your distributors' lawyers get a whiff of the size of civil damages they might receive!
Take the CE Mark seriously, if it not legal: brand it out, permanently obscure it with a tamper proof label or something similar.
... and if the declaration is under MDR - remember you now have the PRRC and EUAR to answer for the criminal and civil penalties.
Just Don't!

Neil

------------------------------
Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom

Original Message:
Sent: 10-Apr-2020 09:55
From: Anonymous Member
Subject: CE mark effect in U.S

This message was posted by a user wishing to remain anonymous

Hello everyone,
Would like to hear your thoughts on the following. We have received FDA clearance for a device which is currently also under review for MDR CE mark. The product has same label in US and EU and the CE mark appears on the label. My question here is can you sell your device in U.S once you have received your FDA clearance if your device has the CE mark symbol and CE mark is not yet granted? I know that CE mark produces effects only in the EU, however I believe it would be misleading to put on US marked a product which apparently states it is CE marked. Do you agree?
Many thanks to you all,

Hi Neil,

I didn't take your response that way, just that you were looking at how the EU/NB might react, while I was looking at it from an FDA perspective.  Arthur probably looked globally and settled on FDA as the applicable jurisdiction, which ultimately, it is.  Now that everyone has put in their two cents, what I think is that those coins have two sides, and we have now thoroughly explored both of them, which is what we are here for, I think.

I think the main reason FDA would have no problem with it is that FDA knows that no one in the US cares about a CE Mark on a medical device, because everyone knows that a medical device must be FDA-whatevered to be sold in the US, and a CE Mark adds nothing to that.  I think this would be called a false claim, but not a material false claim. 

All that said, If I were trying to ship these devices into the US, I think I might be more interested in what customs thinks than FDA, but then I don't know a lot about customs.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 14-Apr-2020 04:53
From: Neil Armstrong
Subject: CE mark effect in U.S

Hi Julie:
Sorry, I was not meaning to imply there was any extra-jurisdictional reach for a CE Mark, just that if it is applied as stated under the MDR, there must be an EUAR and EUAR's PRRC accepting responsibility in Europe. So if the manufacturer is outside Europe it is the EUAR and their PRRC that may be liable. The difficulty in the days of global trade and travel, if we ever return to them, is wherever the product is put on the market, it can end up in Europe and the onus is then on EUAR.
One of the intentions of the new regulations was to produce a more uniform approach to enforcement and prosecuting across the EU - maybe that is no longer likely in the post-Covid 19 world.
However, I believe there is an ethical concern: the CE mark is seen as a badge of safety and performance on which many people rely, and to put it on without proper sanction is as ethically wrong as sticking on other safety or compliance badge without proper authority ... just in the belief the product should pass. The other point is to remember what the CE signifies, that the product complies with all applicable European Regulations and Directives - it is just plain wrong for an ethical business not to take placing it in a product seriously.

------------------------------
Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom

Original Message:
Sent: 14-Apr-2020 01:30
From: Julie Omohundro
Subject: CE mark effect in U.S

If it was fraud in the UK, then the UK must have recognized the CE Mark for market access.  FDA does not. Besides, in the US, you only end up in jail for fraud if you stiff CMS. (That is sort of a joke.)

In the US, only the government can prosecute; all others must sue.  If the NBs sued their customers for apply numbers incorrectly, I'm wondering if that was under the regulations, or per their contractual agreement with their customers.  I've always been under the impression that the NBs have no legal enforcement authority.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Apr-2020 05:47
From: Neil Armstrong
Subject: CE mark effect in U.S

Short answer just don't!
The CE Mark is applied based on a declaration of conformity made by you or your EUAR.
If you know that there is no such valid declaration based on a completed conformity assessment route, but still allow the CE to be applied, it is fraudulently applied.
A criminal offense has most likely been committed in the Manufacturers or EUAR's EU Member State.
Last year a company director was jailed for fraud in the UK.
Last year Notified Bodies prosecuted their customers for applying their numbers incorrectly.
... and just wait till your distributors' lawyers get a whiff of the size of civil damages they might receive!
Take the CE Mark seriously, if it not legal: brand it out, permanently obscure it with a tamper proof label or something similar.
... and if the declaration is under MDR - remember you now have the PRRC and EUAR to answer for the criminal and civil penalties.
Just Don't!

Neil

------------------------------
Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom

Original Message:
Sent: 10-Apr-2020 09:55
From: Anonymous Member
Subject: CE mark effect in U.S

This message was posted by a user wishing to remain anonymous

Hello everyone,
Would like to hear your thoughts on the following. We have received FDA clearance for a device which is currently also under review for MDR CE mark. The product has same label in US and EU and the CE mark appears on the label. My question here is can you sell your device in U.S once you have received your FDA clearance if your device has the CE mark symbol and CE mark is not yet granted? I know that CE mark produces effects only in the EU, however I believe it would be misleading to put on US marked a product which apparently states it is CE marked. Do you agree?
Many thanks to you all,

Looking at all the responses here, I thi k we may be looking at the wrong law.  Putting the CE mark on product supplied in the US may not break any of the FDA administered laws or regulations (although even that is arguable).  But aren't you making a fraudulent claim in the US by representing the product as having an international approval?  If something goes wrong with the product I can see a smart tort lawyer making hay with that.

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com
------------------------------

Original Message:
Sent: 10-Apr-2020 09:55
From: Anonymous Member
Subject: CE mark effect in U.S

This message was posted by a user wishing to remain anonymous

Hello everyone,
Would like to hear your thoughts on the following. We have received FDA clearance for a device which is currently also under review for MDR CE mark. The product has same label in US and EU and the CE mark appears on the label. My question here is can you sell your device in U.S once you have received your FDA clearance if your device has the CE mark symbol and CE mark is not yet granted? I know that CE mark produces effects only in the EU, however I believe it would be misleading to put on US marked a product which apparently states it is CE marked. Do you agree?
Many thanks to you all,

Yes, Arthur, I was thinking that Kellie asked the wrong authority and wondered if Neil missed the fact that these devices will not be sold in the EU, but in the US.

NBs may be fine with it (I'm guessing some would not, but that's more of a business interest than a regulatory interest, I would think.)  However, NBs don't have jurisdiction over what goes on a label for a medical device sold in the US.  That's FDA's jurisdiction.

I can't speak for FDA, but I would look at it as a claim that the product has been doubly blessed, by both FDA and the EU.  And I would consider that to be a false claim.  On the other hand, in the spirit of global cooperation, if the NB had okayed it as Kellie's did, I think FDA would probably be okay with it too.

I wonder what happens if a company advertises a device as "FDA-cleared" in the EU, if the device has not been cleared by FDA?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 13-Apr-2020 19:42
From: Arthur Brandwood
Subject: CE mark effect in U.S

Looking at all the responses here, I thi k we may be looking at the wrong law.  Putting the CE mark on product supplied in the US may not break any of the FDA administered laws or regulations (although even that is arguable).  But aren't you making a fraudulent claim in the US by representing the product as having an international approval?  If something goes wrong with the product I can see a smart tort lawyer making hay with that.

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com

Original Message:
Sent: 10-Apr-2020 09:55
From: Anonymous Member
Subject: CE mark effect in U.S

This message was posted by a user wishing to remain anonymous

Hello everyone,
Would like to hear your thoughts on the following. We have received FDA clearance for a device which is currently also under review for MDR CE mark. The product has same label in US and EU and the CE mark appears on the label. My question here is can you sell your device in U.S once you have received your FDA clearance if your device has the CE mark symbol and CE mark is not yet granted? I know that CE mark produces effects only in the EU, however I believe it would be misleading to put on US marked a product which apparently states it is CE marked. Do you agree?
Many thanks to you all,

No there is no fraudulent claim. As I previous stated, the NB has no jurisdiction in the US. The NB is ok with it. The global label is acceptable. It only becomes an issue if you market a device where you do not have approval. Think of it as if your renewal cert was temporarily delayed to market in EU for a couple of months. You would not change your global label. You would stop shipping to the EU. There is no fraud.

------------------------------
Kellie Stefaniak
Sr. Director Regulatory Affairs
Salt Lake City UT
United States
------------------------------

Original Message:
Sent: 13-Apr-2020 19:42
From: Arthur Brandwood
Subject: CE mark effect in U.S

Looking at all the responses here, I thi k we may be looking at the wrong law.  Putting the CE mark on product supplied in the US may not break any of the FDA administered laws or regulations (although even that is arguable).  But aren't you making a fraudulent claim in the US by representing the product as having an international approval?  If something goes wrong with the product I can see a smart tort lawyer making hay with that.

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com

Original Message:
Sent: 10-Apr-2020 09:55
From: Anonymous Member
Subject: CE mark effect in U.S

This message was posted by a user wishing to remain anonymous

Hello everyone,
Would like to hear your thoughts on the following. We have received FDA clearance for a device which is currently also under review for MDR CE mark. The product has same label in US and EU and the CE mark appears on the label. My question here is can you sell your device in U.S once you have received your FDA clearance if your device has the CE mark symbol and CE mark is not yet granted? I know that CE mark produces effects only in the EU, however I believe it would be misleading to put on US marked a product which apparently states it is CE marked. Do you agree?
Many thanks to you all,

Another wrinkle - many folks have MDSAP certificates, and the same Notified Body may be auditing FOR FDA. While the manufacturer may have controls to keep a product from the EU, the Notified Body may still care if their mark is on products distributed outside of EU but into MDSAP countries. At the very least, it could be a loss of trust between manufacturer and Notified Body.

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
South Jordan UT
United States
------------------------------

Original Message:
Sent: 10-Apr-2020 09:55
From: Anonymous Member
Subject: CE mark effect in U.S

This message was posted by a user wishing to remain anonymous

Hello everyone,
Would like to hear your thoughts on the following. We have received FDA clearance for a device which is currently also under review for MDR CE mark. The product has same label in US and EU and the CE mark appears on the label. My question here is can you sell your device in U.S once you have received your FDA clearance if your device has the CE mark symbol and CE mark is not yet granted? I know that CE mark produces effects only in the EU, however I believe it would be misleading to put on US marked a product which apparently states it is CE marked. Do you agree?
Many thanks to you all,