Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

I was wondering that is it an EU regulatory requirement to mark CE mark directly on reusable surgical instruments such as drill bits, drill guides etc.?

Or is it enough to have the CE mark on the device labels?

We would like to be sure on this point.

What about your companies - do you put CE/CEnnnn mark as a direct mark on your instruments?

Your thoughts would be appreciated.

From the Directive and Regulation, applying the CE Mark is not clearly stated whether it has to be on the actual device or not.  Reading through Point 23 of Annex I from the EU MDR there is information talking about labelling and packaging that also is not specific for applying the CE Mark.  Only direct marking is discussed in conjunction with UDI.  In my experience, I have not known encountered an instance where a regulatory body requires the CE Mark on the actual device itself or specific to your question marked or etched on reusable surgical instruments.  There are larger pieces of equipment or instruments that have the identification label attached directly to the device with the CE Mark so it is "direct marked".  However, for reusable surgical instruments, I am not aware of a specific requirement where the CE Mark must be directly on the device.  Now with that said, we are living in a regulatory world that 1) have a justification/rationale supporting why you put the CE Mark only on the device label and not on the instrument or 2) maybe might be a good idea, if the actual device allows, to etch the CE Mark on the actual device, like you would for the UDI.  This of course depends on the actual device and whether this is technological feasible and does not impact the safety or performance of the device.

Edit: Would like to add some clarifying information that there is indeed interpretation on this point.  If you read Article 20 from the EU MDR: 'Point 3 The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging.'  When reading affixed visibly, legibly, and indelibly ... some interrupt that on the device itself though if you read further if not possible on nature of device.  As stated above, there should be justification/rationale if you do not put the CE Mark directly on the device itself.

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

Original Message:
Sent: 08-Feb-2019 07:57
From: Anonymous Member
Subject: Marking instruments in the EU

This message was posted by a user wishing to remain anonymous

Hi,

I was wondering that is it an EU regulatory requirement to mark CE mark directly on reusable surgical instruments such as drill bits, drill guides etc.?

Or is it enough to have the CE mark on the device labels?

We would like to be sure on this point.

What about your companies - do you put CE/CEnnnn mark as a direct mark on your instruments?

Your thoughts would be appreciated.

This message was posted by a user wishing to remain anonymous

I would think a lack of real estate and/or impact on performance would be two examples where not placing the CE mark on the actual device could be justified. But I don't think either one of those two would apply to a surgical instrument.
Original Message:
Sent: 09-Feb-2019 03:25
From: Richard Vincins
Subject: Marking instruments in the EU

From the Directive and Regulation, applying the CE Mark is not clearly stated whether it has to be on the actual device or not.  Reading through Point 23 of Annex I from the EU MDR there is information talking about labelling and packaging that also is not specific for applying the CE Mark.  Only direct marking is discussed in conjunction with UDI.  In my experience, I have not known encountered an instance where a regulatory body requires the CE Mark on the actual device itself or specific to your question marked or etched on reusable surgical instruments.  There are larger pieces of equipment or instruments that have the identification label attached directly to the device with the CE Mark so it is "direct marked".  However, for reusable surgical instruments, I am not aware of a specific requirement where the CE Mark must be directly on the device.  Now with that said, we are living in a regulatory world that 1) have a justification/rationale supporting why you put the CE Mark only on the device label and not on the instrument or 2) maybe might be a good idea, if the actual device allows, to etch the CE Mark on the actual device, like you would for the UDI.  This of course depends on the actual device and whether this is technological feasible and does not impact the safety or performance of the device.

Edit: Would like to add some clarifying information that there is indeed interpretation on this point.  If you read Article 20 from the EU MDR: 'Point 3 The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging.'  When reading affixed visibly, legibly, and indelibly ... some interrupt that on the device itself though if you read further if not possible on nature of device.  As stated above, there should be justification/rationale if you do not put the CE Mark directly on the device itself.

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

Original Message:
Sent: 08-Feb-2019 07:57
From: Anonymous Member
Subject: Marking instruments in the EU

This message was posted by a user wishing to remain anonymous

Hi,

I was wondering that is it an EU regulatory requirement to mark CE mark directly on reusable surgical instruments such as drill bits, drill guides etc.?

Or is it enough to have the CE mark on the device labels?

We would like to be sure on this point.

What about your companies - do you put CE/CEnnnn mark as a direct mark on your instruments?

Your thoughts would be appreciated.

This message was posted by a user wishing to remain anonymous

For more information on CE marking in general you could check the official 

BLUE GUIDE_2016_EN.

Please note the blue guide is generic,  that that specifics like MDD and MDR may overrule it.

Original Message:
Sent: 11-Feb-2019 17:10
From: Anonymous Member
Subject: Marking instruments in the EU

This message was posted by a user wishing to remain anonymous

I would think a lack of real estate and/or impact on performance would be two examples where not placing the CE mark on the actual device could be justified. But I don't think either one of those two would apply to a surgical instrument.
Original Message:
Sent: 09-Feb-2019 03:25
From: Richard Vincins
Subject: Marking instruments in the EU

From the Directive and Regulation, applying the CE Mark is not clearly stated whether it has to be on the actual device or not.  Reading through Point 23 of Annex I from the EU MDR there is information talking about labelling and packaging that also is not specific for applying the CE Mark.  Only direct marking is discussed in conjunction with UDI.  In my experience, I have not known encountered an instance where a regulatory body requires the CE Mark on the actual device itself or specific to your question marked or etched on reusable surgical instruments.  There are larger pieces of equipment or instruments that have the identification label attached directly to the device with the CE Mark so it is "direct marked".  However, for reusable surgical instruments, I am not aware of a specific requirement where the CE Mark must be directly on the device.  Now with that said, we are living in a regulatory world that 1) have a justification/rationale supporting why you put the CE Mark only on the device label and not on the instrument or 2) maybe might be a good idea, if the actual device allows, to etch the CE Mark on the actual device, like you would for the UDI.  This of course depends on the actual device and whether this is technological feasible and does not impact the safety or performance of the device.

Edit: Would like to add some clarifying information that there is indeed interpretation on this point.  If you read Article 20 from the EU MDR: 'Point 3 The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging.'  When reading affixed visibly, legibly, and indelibly ... some interrupt that on the device itself though if you read further if not possible on nature of device.  As stated above, there should be justification/rationale if you do not put the CE Mark directly on the device itself.

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

Original Message:
Sent: 08-Feb-2019 07:57
From: Anonymous Member
Subject: Marking instruments in the EU

This message was posted by a user wishing to remain anonymous

Hi,

I was wondering that is it an EU regulatory requirement to mark CE mark directly on reusable surgical instruments such as drill bits, drill guides etc.?

Or is it enough to have the CE mark on the device labels?

We would like to be sure on this point.

What about your companies - do you put CE/CEnnnn mark as a direct mark on your instruments?

Your thoughts would be appreciated.

I know a company that puts no CE mark on their drill bits or saw blades on purpose. It is only on the label.

They don't want a reprocessor being able to use their original CE mark to get a product into the hospital. The reprocessor would have to put their own label on the item with the reprocessor's CE mark. That keeps the original manufacturer free from liability if the reprocessor's product is of poor quality. Also, the reporcessor would have to have a CE mark of its own, meaning someone can't reprocess it in their garage and deliver it to a hospital as a CE marked device.

Regards,

------------------------------
John Minier, RAC
Consultant, Principal
john@johnminier.com
(914) 850-4432
Highland Mills, NY
United States
------------------------------

Original Message:
Sent: 08-Feb-2019 07:57
From: Anonymous Member
Subject: Marking instruments in the EU

This message was posted by a user wishing to remain anonymous

Hi,

I was wondering that is it an EU regulatory requirement to mark CE mark directly on reusable surgical instruments such as drill bits, drill guides etc.?

Or is it enough to have the CE mark on the device labels?

We would like to be sure on this point.

What about your companies - do you put CE/CEnnnn mark as a direct mark on your instruments?

Your thoughts would be appreciated.