Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

What is protocol for CE Marking on individual package labels for Class I instruments that are part of a system containing Class IIb implants?  The associated IFU contains CE+NB#. Also, looking for clear guidance documents on CE Marking.

There probably needs to be a bit more information from you to understand what aspects of packaging, labelling, and CE Marking you are trying to do.  Will try to answer your scenario as best can but not sure exact information can be provided.  In regard to individual packages of Class I, instruments, currently you just need to apply the CE Mark on the product label.  If they are individually packaged this should be clear because you can co-package products together, but if they are different classes then each should have its own label.  In particular if they are sold separately as well.  However, in the future under the Medical Device Regulation 2017/745 EU reusable surgical implants will require Notified Body intervention, therefore the actual CE Mark on the label needs to contain the NB number as well.

If the products are being sold as a system, i.e. Class I and IIb together, my personal opinion is the IFU can contain the CE Mark and NB number.  There can be sort of a presumption that the individual components of the system as a Class I and Class IIb products would be address overall by one IFU.  I would strongly recommend that your technical documentation clearly describe the relationship of the packaging, packaging levels, individual packaged products, labelling, and IFU, so that an NB reviewer would not necessarily lump all the products together.  This again is important to distinguish if your company also sells the Class I instruments separately.  Then asking the question do they get their own IFU or is the "system" IFU imagine to cover all of these as well.

Sorry but your last statement looking for clear guidance on CE Marking is very general, I am not sure how to address that point.

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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 01-Jun-2018 10:45
From: Anonymous Member
Subject: CE Marking Package Labels

This message was posted by a user wishing to remain anonymous

What is protocol for CE Marking on individual package labels for Class I instruments that are part of a system containing Class IIb implants?  The associated IFU contains CE+NB#. Also, looking for clear guidance documents on CE Marking.

This message was posted by a user wishing to remain anonymous

Thank you Richard and Uwe for your responses. Our product (Class IIb implants plus instruments, mostly Class I) is initially packaged in an anodized aluminum sterilization tray(s),  Components sold to replenish the tray(s) are packaged, labeled and shipped separately.  Some customers prefer that all components be individually packaged and labeled. The IFU is supposed to cover the whole sytem.

Original Message:
Sent: 02-Jun-2018 03:16
From: Richard Vincins
Subject: CE Marking Package Labels

There probably needs to be a bit more information from you to understand what aspects of packaging, labelling, and CE Marking you are trying to do.  Will try to answer your scenario as best can but not sure exact information can be provided.  In regard to individual packages of Class I, instruments, currently you just need to apply the CE Mark on the product label.  If they are individually packaged this should be clear because you can co-package products together, but if they are different classes then each should have its own label.  In particular if they are sold separately as well.  However, in the future under the Medical Device Regulation 2017/745 EU reusable surgical implants will require Notified Body intervention, therefore the actual CE Mark on the label needs to contain the NB number as well.

If the products are being sold as a system, i.e. Class I and IIb together, my personal opinion is the IFU can contain the CE Mark and NB number.  There can be sort of a presumption that the individual components of the system as a Class I and Class IIb products would be address overall by one IFU.  I would strongly recommend that your technical documentation clearly describe the relationship of the packaging, packaging levels, individual packaged products, labelling, and IFU, so that an NB reviewer would not necessarily lump all the products together.  This again is important to distinguish if your company also sells the Class I instruments separately.  Then asking the question do they get their own IFU or is the "system" IFU imagine to cover all of these as well.

Sorry but your last statement looking for clear guidance on CE Marking is very general, I am not sure how to address that point.

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

Original Message:
Sent: 01-Jun-2018 10:45
From: Anonymous Member
Subject: CE Marking Package Labels

This message was posted by a user wishing to remain anonymous

What is protocol for CE Marking on individual package labels for Class I instruments that are part of a system containing Class IIb implants?  The associated IFU contains CE+NB#. Also, looking for clear guidance documents on CE Marking.

Hello,

I wonder, if are you talking about a system where the class I product is in the same package as the class IIb implant? And that these are sterilized together in the same protective package and the package is opened "only" at the time of use?

In that case, a system declaration based on MDD article 12 might help. In a procedure pack, you do not need (if supported by risk management) individuell bags (and hence individual labeling). In my understanding of subsection 2, you can go with a joint instruction. This IFU needs to explain that the implant is class IIb from manufacturer A and the instrument is class I from manufacturer B. …… In your technical file(s), you than need to have two separat DoC's (class IIb + class I) and you will need add your article 12 declaration.

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Uwe Zeller | Regulatory Affairs / Risk Management Consultant
Biberach an der Riß, Germany
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Original Message:
Sent: 01-Jun-2018 10:45
From: Anonymous Member
Subject: CE Marking Package Labels

This message was posted by a user wishing to remain anonymous

What is protocol for CE Marking on individual package labels for Class I instruments that are part of a system containing Class IIb implants?  The associated IFU contains CE+NB#. Also, looking for clear guidance documents on CE Marking.