Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello, 

Have you gone through the process of changing notified body? Can you provide information of what it entails? The company sells product all over the world and trying to get an of what it will entail (audits/labeling change etc. etc)

This is a great challenge at the moment.  There are so many factors to consider but just a short list:

• Finding a Notified Body that you can actually switch to - one that will give you a quotation
• Transitioning in the timeframe that you need - many are months out scheduling audits
• Your current QMS status with NB such as open corrective actions or changes being reviewed
• Usually changing Notified Body requires a full new assessment, just because you have a current certification or CE Mark does not mean that you can get an "abridged" certification audit
• And transitioning to Medical Device Regulation/In Vitro Diagnostic Regulation; some may not take on new clients until their are designated under new regulations because theoretically they can not provide CE Mark to the MDD/IVDD now that the force of entry is in place

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

Original Message:
Sent: 03-Apr-2018 12:39
From: Anonymous Member
Subject: Changing Notified Body

This message was posted by a user wishing to remain anonymous

Hello,

Have you gone through the process of changing notified body? Can you provide information of what it entails? The company sells product all over the world and trying to get an of what it will entail (audits/labeling change etc. etc)

This message was posted by a user wishing to remain anonymous

In my experience this is how it worked........

Apart from your company having to update all technical files, labeling and internal documentation to reflect this change, the new NB will want to see audit reports from the old NB to be assured that any outstanding NCs were adequately addressed.

They will audit your technical files before issuing your EC certificate. The number of TF audited may depend on the classification of  your device(s).

If this new NB will be responsible for certifying your QS, they may require an audit of your QS before issuing the ISO cert.

The old NB will mandate when CE marked product with their NB ID number can no longer be placed on the market. This information will be provided to you in writing. Not sure if that is something they negotiate with the new NB.
Original Message:
Sent: 03-Apr-2018 12:39
From: Anonymous Member
Subject: Changing Notified Body

This message was posted by a user wishing to remain anonymous

Hello,

Have you gone through the process of changing notified body? Can you provide information of what it entails? The company sells product all over the world and trying to get an of what it will entail (audits/labeling change etc. etc)

Can someone expand on "no longer can be placed on the market" ? Does this mean from the time you become certified with the new Notified Body? What about existing CE marked devices that have already been placed on the market with the previous Notified Body #? Can you deplete stock on the devices with the previous Notified Body CE # while placing devices on market the new Notified Body's CE Marked devices?​​

------------------------------
[Ponzelle [Royster] [RAC]
[Manager QA / RA, US & Canadian Region]
[Sol-Millennium Medical, Inc.]
[Lawrenceville, [GA]
[USA]
------------------------------

Original Message:
Sent: 04-Apr-2018 11:28
From: Anonymous Member
Subject: Changing Notified Body

This message was posted by a user wishing to remain anonymous

In my experience this is how it worked........

Apart from your company having to update all technical files, labeling and internal documentation to reflect this change, the new NB will want to see audit reports from the old NB to be assured that any outstanding NCs were adequately addressed.

They will audit your technical files before issuing your EC certificate. The number of TF audited may depend on the classification of  your device(s).

If this new NB will be responsible for certifying your QS, they may require an audit of your QS before issuing the ISO cert.

The old NB will mandate when CE marked product with their NB ID number can no longer be placed on the market. This information will be provided to you in writing. Not sure if that is something they negotiate with the new NB.
Original Message:
Sent: 03-Apr-2018 12:39
From: Anonymous Member
Subject: Changing Notified Body

This message was posted by a user wishing to remain anonymous

Hello,

Have you gone through the process of changing notified body? Can you provide information of what it entails? The company sells product all over the world and trying to get an of what it will entail (audits/labeling change etc. etc)

Original Message------


Can someone expand on "no longer can be placed on the market" ? Does this mean from the time you become certified with the new Notified Body? What about existing CE marked devices that have already been placed on the market with the previous Notified Body #? Can you deplete stock on the devices with the previous Notified Body CE # while placing devices on market the new Notified Body's CE Marked devices?​​

------------------------------
[Ponzelle [Royster] [RAC]
[Manager QA / RA, US & Canadian Region]
[Sol-Millennium Medical, Inc.]
[Lawrenceville, [GA]
[USA]
------------------------------

​You will find helpful guidance in this document. Everything that is already placed on the marked (i.e. imported in the EU with a view to further distribute in the EU), can continue to be distributed. What is still in your warehouse outside of the EU, would need to be relabelled after the transition period negotiated with the NB (old and new).

http://www.doks.nbog.eu/Doks/NBOG_BPG_2006_1.pdf

------------------------------
Andrea Sparti PhD, SCD
Regulatory Affairs Manager
Bienne
Switzerland
------------------------------

Original Message:
Sent: 05-Apr-2018 09:00
From: Tim White
Subject: Changing Notified Body

My situation was a current NB that merged with another NB, resulting in a CE # change.  We were required to have a single cut-off date for all devices.  We could not ship devices with the old CE # after the cut-off date.  However, we were able to buy inexpensive stickers with the new CE # to place over the old CE # and then ship the existing inventory.

 

Tim White | Quality Assurance
ASQ - Certified Manager of Quality/Organizational Excellence (CMQOE)

ASQ - Certified Quality Engineer (CQE)

ASQ - Certified Six Sigma Green Belt (CSSGB)

Certified Lead Auditor

Certified Biological Safety Specialist
P:  740-548-4100 x2107  •  www.abrasive-tech.com

twhite@abrasive-tech.com

 

Original Message------


Can someone expand on "no longer can be placed on the market" ? Does this mean from the time you become certified with the new Notified Body? What about existing CE marked devices that have already been placed on the market with the previous Notified Body #? Can you deplete stock on the devices with the previous Notified Body CE # while placing devices on market the new Notified Body's CE Marked devices?​​

------------------------------
[Ponzelle [Royster] [RAC]
[Manager QA / RA, US & Canadian Region]
[Sol-Millennium Medical, Inc.]
[Lawrenceville, [GA]
[USA]
------------------------------

This message was posted by a user wishing to remain anonymous

My experience involved changing from one current (prominent) NB to another current (prominent) NB. Regarding change over dates, any new mfg performed after the cutoff date was CE marked under the new NB EC Cert and was therefore labeled with the new NB ID number.
Any product manufactured and placed on the market (i.e. in our Finished Goods warehouse, at the distributor, sold etc) under the original NB EC certificate did not have to be relabeled as all of those activities were done under the certs of the first NB.
Original Message:
Sent: 04-Apr-2018 18:38
From: Ponzelle Royster
Subject: Changing Notified Body


Can someone expand on "no longer can be placed on the market" ? Does this mean from the time you become certified with the new Notified Body? What about existing CE marked devices that have already been placed on the market with the previous Notified Body #? Can you deplete stock on the devices with the previous Notified Body CE # while placing devices on market the new Notified Body's CE Marked devices?​​

------------------------------
[Ponzelle [Royster] [RAC]
[Manager QA / RA, US & Canadian Region]
[Sol-Millennium Medical, Inc.]
[Lawrenceville, [GA]
[USA]

Original Message:
Sent: 04-Apr-2018 11:28
From: Anonymous Member
Subject: Changing Notified Body

This message was posted by a user wishing to remain anonymous

In my experience this is how it worked........

Apart from your company having to update all technical files, labeling and internal documentation to reflect this change, the new NB will want to see audit reports from the old NB to be assured that any outstanding NCs were adequately addressed.

They will audit your technical files before issuing your EC certificate. The number of TF audited may depend on the classification of  your device(s).

If this new NB will be responsible for certifying your QS, they may require an audit of your QS before issuing the ISO cert.

The old NB will mandate when CE marked product with their NB ID number can no longer be placed on the market. This information will be provided to you in writing. Not sure if that is something they negotiate with the new NB.
Original Message:
Sent: 03-Apr-2018 12:39
From: Anonymous Member
Subject: Changing Notified Body

This message was posted by a user wishing to remain anonymous

Hello,

Have you gone through the process of changing notified body? Can you provide information of what it entails? The company sells product all over the world and trying to get an of what it will entail (audits/labeling change etc. etc)