Regulatory Open Forum

Due to Brexit BSI issued us two separate  NB numbers: BSI UK 0086 & BSI Netherlands 2797.  Both are currently valid.  Eventually all of our products will fall under the Netherlands office but how do we label our products in the meantime??  Do we list both numbers? 

BSI has offered no guidance on this.

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Kathleen Preston
Sr. Regulatory and Compliance Specialist
Ruckersville VA
United States
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Two NB numbers with a CE mark ​normally means you had different NBs assessing against different regulations or directives applicable to the device.

In this case, I'd just label with the one you're transitioning to. But if you happen to have things already labeled with the old number, you can continue shipping them for a while. They don't have to be reworked with the new number immediately, since the old number remains valid during this transition.

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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 07-Feb-2020 09:08
From: Kathleen Preston
Subject: CE marking with two NB numbers

Due to Brexit BSI issued us two separate  NB numbers: BSI UK 0086 & BSI Netherlands 2797.  Both are currently valid.  Eventually all of our products will fall under the Netherlands office but how do we label our products in the meantime??  Do we list both numbers? 

BSI has offered no guidance on this.

------------------------------
Kathleen Preston
Sr. Regulatory and Compliance Specialist
Ruckersville VA
United States
------------------------------

Only use one of the numbers. If you have a valid CE Certificate under the new NB number from Netherlands, which you are transitioning to, then use that one.  At least you have the advantage to switch over and transition your packaging and labelling.  Some companies don't have that choice where they get stuck waiting for a certificate to be issued.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 07-Feb-2020 10:01
From: Anne LeBlanc
Subject: CE marking with two NB numbers

Two NB numbers with a CE mark ​normally means you had different NBs assessing against different regulations or directives applicable to the device.

In this case, I'd just label with the one you're transitioning to. But if you happen to have things already labeled with the old number, you can continue shipping them for a while. They don't have to be reworked with the new number immediately, since the old number remains valid during this transition.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 07-Feb-2020 09:08
From: Kathleen Preston
Subject: CE marking with two NB numbers

Due to Brexit BSI issued us two separate  NB numbers: BSI UK 0086 & BSI Netherlands 2797.  Both are currently valid.  Eventually all of our products will fall under the Netherlands office but how do we label our products in the meantime??  Do we list both numbers? 

BSI has offered no guidance on this.

------------------------------
Kathleen Preston
Sr. Regulatory and Compliance Specialist
Ruckersville VA
United States
------------------------------

BSI required us to provide a plan and a projected completion data as to when we are transitioning CE numbers.  After that final data we are no longer allowed to use 0086.  We are currently transitioning product by product based on material considerations and such.