Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello 
Hope you're all doing well!

I am currently working with a Medical Device company  that I joined a month ago and this is my first job. 
The company had quite a few non-conformances from their last notified body audit for ISO:13485 compliance. We showed the audit report to one of our internal auditors who comes in once every year and he pointed out to us that many of the non conformances are just unnecessary and unfair. 

They are very difficult to reason with. They never respond to any of our queries and we end up chasing them for weeks with no answer. 
I was thinking about changing the notified body, preferably prior to the new ISO 13485:2016 version coming into effect, but we heard from a few people that changing your notified body is not a good idea. But we seem to be getting nowhere with these guys working so non-cooperatively. 

Is changing the notified body a bad idea and what are the factors to take into consideration before changing?

Thanks

Regards,
Anonymous

It is a certification body that issues the ISO 13485 certificate. The notified body, and this can be different from the certification body, issues the declaration of conformity and allows you to CE mark with their number. This causes a lot of confusion as it is not always made clear. Speak to your business manager at the certification body. I have never changed certification body, so I have no idea how feasible this is, though I have considered it

------------------------------
Patrick Druggan
Head of Regulatory Affairs
Wirral
United Kingdom
------------------------------

Original Message:
Sent: 01-Oct-2018 13:44
From: Anonymous Member
Subject: Change of Notified Body

This message was posted by a user wishing to remain anonymous

Hello
Hope you're all doing well!

I am currently working with a Medical Device company  that I joined a month ago and this is my first job.
The company had quite a few non-conformances from their last notified body audit for ISO:13485 compliance. We showed the audit report to one of our internal auditors who comes in once every year and he pointed out to us that many of the non conformances are just unnecessary and unfair.

They are very difficult to reason with. They never respond to any of our queries and we end up chasing them for weeks with no answer.
I was thinking about changing the notified body, preferably prior to the new ISO 13485:2016 version coming into effect, but we heard from a few people that changing your notified body is not a good idea. But we seem to be getting nowhere with these guys working so non-cooperatively.

Is changing the notified body a bad idea and what are the factors to take into consideration before changing?

Thanks

Regards,
Anonymous

As Patrick mentioned there is a difference between companies that are auditing for certification: Notified Bodies are for CE Marking (which can include ISO 13485), Registrars are for ISO 13485 certification, Auditing Organisations are for MDSAP.

If you are talking about changing Notified Bodies because your product is CE Marked, the only advice which is not great is good luck changing now.  First, if you can even get a quote from another Notified Body that is your first hurdle.  But currently with companies trying to renew MDD certificates and those preparing for MDR, they all have a lot in their work portfolios.

There are some options with your current Notified Body such as have frank discussions with your project manager or scheme manager.  You could request a different auditor explaining the challenges you are having with resolution of audit findings.  Try to work with your Notified Body, but today that it probably easier said then done.

If you are not CE Marking product and just need ISO 13485 certification, there are plenty of other Registrars out there.

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

Original Message:
Sent: 01-Oct-2018 16:10
From: Patrick Druggan
Subject: Change of Notified Body

It is a certification body that issues the ISO 13485 certificate. The notified body, and this can be different from the certification body, issues the declaration of conformity and allows you to CE mark with their number. This causes a lot of confusion as it is not always made clear. Speak to your business manager at the certification body. I have never changed certification body, so I have no idea how feasible this is, though I have considered it

------------------------------
Patrick Druggan
Head of Regulatory Affairs
Wirral
United Kingdom

Original Message:
Sent: 01-Oct-2018 13:44
From: Anonymous Member
Subject: Change of Notified Body

This message was posted by a user wishing to remain anonymous

Hello
Hope you're all doing well!

I am currently working with a Medical Device company  that I joined a month ago and this is my first job.
The company had quite a few non-conformances from their last notified body audit for ISO:13485 compliance. We showed the audit report to one of our internal auditors who comes in once every year and he pointed out to us that many of the non conformances are just unnecessary and unfair.

They are very difficult to reason with. They never respond to any of our queries and we end up chasing them for weeks with no answer.
I was thinking about changing the notified body, preferably prior to the new ISO 13485:2016 version coming into effect, but we heard from a few people that changing your notified body is not a good idea. But we seem to be getting nowhere with these guys working so non-cooperatively.

Is changing the notified body a bad idea and what are the factors to take into consideration before changing?

Thanks

Regards,
Anonymous

This message was posted by a user wishing to remain anonymous

Hi Richard

Thank you for the clarification. I was under the impression that the DoC, CE marking certificate and ISO 13485 certification is all given by Notified Bodies. 
So our company has the CE certificate from the Notified Body that expires in 2021. But the ISO 13485:2003 certificate expires in March, 2018. 
Would it affect our CE Certificate's validity if we got the ISO 13485:2016 certification from a Registrar or a different Notified Body at this time?
We do have another Notified Body in sight who seem to be more feasible and cooperative to our timelines and they have already provided a quote which works with us. 

Regards,
Anonymous

Original Message:
Sent: 02-Oct-2018 02:04
From: Richard Vincins
Subject: Change of Notified Body

As Patrick mentioned there is a difference between companies that are auditing for certification: Notified Bodies are for CE Marking (which can include ISO 13485), Registrars are for ISO 13485 certification, Auditing Organisations are for MDSAP.

If you are talking about changing Notified Bodies because your product is CE Marked, the only advice which is not great is good luck changing now.  First, if you can even get a quote from another Notified Body that is your first hurdle.  But currently with companies trying to renew MDD certificates and those preparing for MDR, they all have a lot in their work portfolios.

There are some options with your current Notified Body such as have frank discussions with your project manager or scheme manager.  You could request a different auditor explaining the challenges you are having with resolution of audit findings.  Try to work with your Notified Body, but today that it probably easier said then done.

If you are not CE Marking product and just need ISO 13485 certification, there are plenty of other Registrars out there.

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

Original Message:
Sent: 01-Oct-2018 16:10
From: Patrick Druggan
Subject: Change of Notified Body

It is a certification body that issues the ISO 13485 certificate. The notified body, and this can be different from the certification body, issues the declaration of conformity and allows you to CE mark with their number. This causes a lot of confusion as it is not always made clear. Speak to your business manager at the certification body. I have never changed certification body, so I have no idea how feasible this is, though I have considered it

------------------------------
Patrick Druggan
Head of Regulatory Affairs
Wirral
United Kingdom

Original Message:
Sent: 01-Oct-2018 13:44
From: Anonymous Member
Subject: Change of Notified Body

This message was posted by a user wishing to remain anonymous

Hello
Hope you're all doing well!

I am currently working with a Medical Device company  that I joined a month ago and this is my first job.
The company had quite a few non-conformances from their last notified body audit for ISO:13485 compliance. We showed the audit report to one of our internal auditors who comes in once every year and he pointed out to us that many of the non conformances are just unnecessary and unfair.

They are very difficult to reason with. They never respond to any of our queries and we end up chasing them for weeks with no answer.
I was thinking about changing the notified body, preferably prior to the new ISO 13485:2016 version coming into effect, but we heard from a few people that changing your notified body is not a good idea. But we seem to be getting nowhere with these guys working so non-cooperatively.

Is changing the notified body a bad idea and what are the factors to take into consideration before changing?

Thanks

Regards,
Anonymous

Let me clarify, while you can get CE Mark (review of technical documentation and review of QMS) by a Notified Body (Company A) and get your ISO 13485:2016 certification from a Registrar (Company B), this would not be beneficial.  One you would be paying twice as much, and two a NB Company A would still be looking at your QMS that Company B looked at.  In fact, under the MDR it is more difficult to have multiple NBs involved in assessment/certification.  As Kevin stated many NB are also Registrars.

It does not matter if your CE Certificate expires differently from your QMS certificate, in fact it usually will never stayed aligned ... CE Certs up to 5 year expiration and QMS certs 3 year expiration (and I use the term expiration loosely).  If you need to update your QMS to ISO 31485:2016 now, it would be beneficial to change your NB now, so they would issue new QMS Cert as well issue a new CE Cert.  The time is running out for transition to MDR, that if your organisation may not be ready to transition to MDR by 2021, then it would also be beneficial to get a 5 year CE certificate now giving you a couple more years on the certificate.

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

Original Message:
Sent: 02-Oct-2018 13:35
From: Anonymous Member
Subject: Change of Notified Body

This message was posted by a user wishing to remain anonymous

Hi Richard

Thank you for the clarification. I was under the impression that the DoC, CE marking certificate and ISO 13485 certification is all given by Notified Bodies.
So our company has the CE certificate from the Notified Body that expires in 2021. But the ISO 13485:2003 certificate expires in March, 2018.
Would it affect our CE Certificate's validity if we got the ISO 13485:2016 certification from a Registrar or a different Notified Body at this time?
We do have another Notified Body in sight who seem to be more feasible and cooperative to our timelines and they have already provided a quote which works with us.

Regards,
Anonymous

Original Message:
Sent: 02-Oct-2018 02:04
From: Richard Vincins
Subject: Change of Notified Body

As Patrick mentioned there is a difference between companies that are auditing for certification: Notified Bodies are for CE Marking (which can include ISO 13485), Registrars are for ISO 13485 certification, Auditing Organisations are for MDSAP.

If you are talking about changing Notified Bodies because your product is CE Marked, the only advice which is not great is good luck changing now.  First, if you can even get a quote from another Notified Body that is your first hurdle.  But currently with companies trying to renew MDD certificates and those preparing for MDR, they all have a lot in their work portfolios.

There are some options with your current Notified Body such as have frank discussions with your project manager or scheme manager.  You could request a different auditor explaining the challenges you are having with resolution of audit findings.  Try to work with your Notified Body, but today that it probably easier said then done.

If you are not CE Marking product and just need ISO 13485 certification, there are plenty of other Registrars out there.

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

Original Message:
Sent: 01-Oct-2018 16:10
From: Patrick Druggan
Subject: Change of Notified Body

It is a certification body that issues the ISO 13485 certificate. The notified body, and this can be different from the certification body, issues the declaration of conformity and allows you to CE mark with their number. This causes a lot of confusion as it is not always made clear. Speak to your business manager at the certification body. I have never changed certification body, so I have no idea how feasible this is, though I have considered it

------------------------------
Patrick Druggan
Head of Regulatory Affairs
Wirral
United Kingdom

Original Message:
Sent: 01-Oct-2018 13:44
From: Anonymous Member
Subject: Change of Notified Body

This message was posted by a user wishing to remain anonymous

Hello
Hope you're all doing well!

I am currently working with a Medical Device company  that I joined a month ago and this is my first job.
The company had quite a few non-conformances from their last notified body audit for ISO:13485 compliance. We showed the audit report to one of our internal auditors who comes in once every year and he pointed out to us that many of the non conformances are just unnecessary and unfair.

They are very difficult to reason with. They never respond to any of our queries and we end up chasing them for weeks with no answer.
I was thinking about changing the notified body, preferably prior to the new ISO 13485:2016 version coming into effect, but we heard from a few people that changing your notified body is not a good idea. But we seem to be getting nowhere with these guys working so non-cooperatively.

Is changing the notified body a bad idea and what are the factors to take into consideration before changing?

Thanks

Regards,
Anonymous

This message was posted by a user wishing to remain anonymous

Oh, I didn't know the difference between them either. Thank you for the clarification, Patrick. 

Regards,
Anonymous
Original Message:
Sent: 01-Oct-2018 16:10
From: Patrick Druggan
Subject: Change of Notified Body

It is a certification body that issues the ISO 13485 certificate. The notified body, and this can be different from the certification body, issues the declaration of conformity and allows you to CE mark with their number. This causes a lot of confusion as it is not always made clear. Speak to your business manager at the certification body. I have never changed certification body, so I have no idea how feasible this is, though I have considered it

------------------------------
Patrick Druggan
Head of Regulatory Affairs
Wirral
United Kingdom

Original Message:
Sent: 01-Oct-2018 13:44
From: Anonymous Member
Subject: Change of Notified Body

This message was posted by a user wishing to remain anonymous

Hello
Hope you're all doing well!

I am currently working with a Medical Device company  that I joined a month ago and this is my first job.
The company had quite a few non-conformances from their last notified body audit for ISO:13485 compliance. We showed the audit report to one of our internal auditors who comes in once every year and he pointed out to us that many of the non conformances are just unnecessary and unfair.

They are very difficult to reason with. They never respond to any of our queries and we end up chasing them for weeks with no answer.
I was thinking about changing the notified body, preferably prior to the new ISO 13485:2016 version coming into effect, but we heard from a few people that changing your notified body is not a good idea. But we seem to be getting nowhere with these guys working so non-cooperatively.

Is changing the notified body a bad idea and what are the factors to take into consideration before changing?

Thanks

Regards,
Anonymous

I made such a change a few years ago from one Notified Body (that was also a Registrar, which is common) to another Notified Body/Registrar.  It was painful but a highly beneficial change, as the new Notified Body was more openly communicative, flexible, and timely in relation to issuance of the respective certificates (MONTHS sooner than the previous Notified Body).  The overall business benefit was more rapid commercialization of medical devices in the EU.

That stated, Richard Vincins was right-on in mentioning that the timing of such a change might be difficult.  Notified Bodies are understaffed and swamped.  Some are actually turning away new business until the dust settles with the issuance of new certifications related to firms transitioning to the new MDRs, MDSAP, ISO 13485:2016, etc.  Everything is in flux, and it's a potential nightmare.

That stated, this should not prevent you from at least initiating confidential discussions with another Notified Body. 

In terms of identifying the optimal Notified Body for your company, I recommend a good place to start is to identify the Notified Body being used by your successful competitors in the EU marketplace.  This can be done by locating the Notified Body 4-digit identification number adjacent to the CE Mark on competitor product labeling.  The Notified Body associated with that number is available at: http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.pdf&refe_cd=93%2F42%2FEEC&requesttimeout=900

I offer this up as a potential strategy because a Notified Body with experience in auditing Technical Files/Design Dossiers for products similar to yours will likely be better prepared to audit/review similar technical information (performance data, risk analyses, clinical evaluations, post-market info, etc.).  Perhaps also less likely to put document  non-conformances which are really unnecessary or off the mark.

You will also know from the competitive labeling and CE Mark number whether your products fit within the area(s) of responsibility of your new Notified Body.

Good luck!

Kevin

----------------

Kevin Daly Consulting, LLC

kevinedaly@gmail.com

------------------------------
Kevin Daly
Encinitas CA
United States
------------------------------

Original Message:
Sent: 02-Oct-2018 13:36
From: Anonymous Member
Subject: Change of Notified Body

This message was posted by a user wishing to remain anonymous

Oh, I didn't know the difference between them either. Thank you for the clarification, Patrick.

Regards,
Anonymous
Original Message:
Sent: 01-Oct-2018 16:10
From: Patrick Druggan
Subject: Change of Notified Body

It is a certification body that issues the ISO 13485 certificate. The notified body, and this can be different from the certification body, issues the declaration of conformity and allows you to CE mark with their number. This causes a lot of confusion as it is not always made clear. Speak to your business manager at the certification body. I have never changed certification body, so I have no idea how feasible this is, though I have considered it

------------------------------
Patrick Druggan
Head of Regulatory Affairs
Wirral
United Kingdom

Original Message:
Sent: 01-Oct-2018 13:44
From: Anonymous Member
Subject: Change of Notified Body

This message was posted by a user wishing to remain anonymous

Hello
Hope you're all doing well!

I am currently working with a Medical Device company  that I joined a month ago and this is my first job.
The company had quite a few non-conformances from their last notified body audit for ISO:13485 compliance. We showed the audit report to one of our internal auditors who comes in once every year and he pointed out to us that many of the non conformances are just unnecessary and unfair.

They are very difficult to reason with. They never respond to any of our queries and we end up chasing them for weeks with no answer.
I was thinking about changing the notified body, preferably prior to the new ISO 13485:2016 version coming into effect, but we heard from a few people that changing your notified body is not a good idea. But we seem to be getting nowhere with these guys working so non-cooperatively.

Is changing the notified body a bad idea and what are the factors to take into consideration before changing?

Thanks

Regards,
Anonymous

This message was posted by a user wishing to remain anonymous

Thank you Kevin and Richard!

That was really helpful. Will consolidate all the info and speak to my manager regarding our options. 

Thanks again
Regards,
Anonymous
Original Message:
Sent: 02-Oct-2018 16:14
From: Kevin Daly
Subject: Change of Notified Body

I made such a change a few years ago from one Notified Body (that was also a Registrar, which is common) to another Notified Body/Registrar.  It was painful but a highly beneficial change, as the new Notified Body was more openly communicative, flexible, and timely in relation to issuance of the respective certificates (MONTHS sooner than the previous Notified Body).  The overall business benefit was more rapid commercialization of medical devices in the EU.

That stated, Richard Vincins was right-on in mentioning that the timing of such a change might be difficult.  Notified Bodies are understaffed and swamped.  Some are actually turning away new business until the dust settles with the issuance of new certifications related to firms transitioning to the new MDRs, MDSAP, ISO 13485:2016, etc.  Everything is in flux, and it's a potential nightmare.

That stated, this should not prevent you from at least initiating confidential discussions with another Notified Body. 

In terms of identifying the optimal Notified Body for your company, I recommend a good place to start is to identify the Notified Body being used by your successful competitors in the EU marketplace.  This can be done by locating the Notified Body 4-digit identification number adjacent to the CE Mark on competitor product labeling.  The Notified Body associated with that number is available at: http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.pdf&refe_cd=93%2F42%2FEEC&requesttimeout=900

I offer this up as a potential strategy because a Notified Body with experience in auditing Technical Files/Design Dossiers for products similar to yours will likely be better prepared to audit/review similar technical information (performance data, risk analyses, clinical evaluations, post-market info, etc.).  Perhaps also less likely to put document  non-conformances which are really unnecessary or off the mark.

You will also know from the competitive labeling and CE Mark number whether your products fit within the area(s) of responsibility of your new Notified Body.

Good luck!

Kevin

----------------

Kevin Daly Consulting, LLC

kevinedaly@gmail.com

------------------------------
Kevin Daly
Encinitas CA
United States

Original Message:
Sent: 02-Oct-2018 13:36
From: Anonymous Member
Subject: Change of Notified Body

This message was posted by a user wishing to remain anonymous

Oh, I didn't know the difference between them either. Thank you for the clarification, Patrick.

Regards,
Anonymous
Original Message:
Sent: 01-Oct-2018 16:10
From: Patrick Druggan
Subject: Change of Notified Body

It is a certification body that issues the ISO 13485 certificate. The notified body, and this can be different from the certification body, issues the declaration of conformity and allows you to CE mark with their number. This causes a lot of confusion as it is not always made clear. Speak to your business manager at the certification body. I have never changed certification body, so I have no idea how feasible this is, though I have considered it

------------------------------
Patrick Druggan
Head of Regulatory Affairs
Wirral
United Kingdom

Original Message:
Sent: 01-Oct-2018 13:44
From: Anonymous Member
Subject: Change of Notified Body

This message was posted by a user wishing to remain anonymous

Hello
Hope you're all doing well!

I am currently working with a Medical Device company  that I joined a month ago and this is my first job.
The company had quite a few non-conformances from their last notified body audit for ISO:13485 compliance. We showed the audit report to one of our internal auditors who comes in once every year and he pointed out to us that many of the non conformances are just unnecessary and unfair.

They are very difficult to reason with. They never respond to any of our queries and we end up chasing them for weeks with no answer.
I was thinking about changing the notified body, preferably prior to the new ISO 13485:2016 version coming into effect, but we heard from a few people that changing your notified body is not a good idea. But we seem to be getting nowhere with these guys working so non-cooperatively.

Is changing the notified body a bad idea and what are the factors to take into consideration before changing?

Thanks

Regards,
Anonymous