Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,

Is there a process by which groups, such as bsi or TUV sud, perform pre-reviews of technical documentation prior to a company submitting an application? I guess it would be sort of like a pre-submission request in the US, except one would have to pay for it. I thought I saw this somewhere but not I cannot find it as a service.

Hi,

no Notified Body is allowed to do any part or sub-part of a Conformity Assessment (like e.g. pre-reviews of technical documentation) without an application.

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Klaus-Dieter Ziel
Hamburg
Germany
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Original Message:
Sent: 31-Jul-2019 14:22
From: Anonymous Member
Subject: Notified Body Review

This message was posted by a user wishing to remain anonymous

Hi All,

Is there a process by which groups, such as bsi or TUV sud, perform pre-reviews of technical documentation prior to a company submitting an application? I guess it would be sort of like a pre-submission request in the US, except one would have to pay for it. I thought I saw this somewhere but not I cannot find it as a service.

Some NBs used to offer this type of service, Anon, such as reviewing clinical strategy documents, but the European Commission has recently deemed such activity to be "consultancy" which, under the MDD/MDR, NBs are not allowed to provide. So the simple answer is "No".

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 31-Jul-2019 14:22
From: Anonymous Member
Subject: Notified Body Review

This message was posted by a user wishing to remain anonymous

Hi All,

Is there a process by which groups, such as bsi or TUV sud, perform pre-reviews of technical documentation prior to a company submitting an application? I guess it would be sort of like a pre-submission request in the US, except one would have to pay for it. I thought I saw this somewhere but not I cannot find it as a service.

Unfortunately the benefit of doing something like Pre-Submiission/Q-Submission via the U.S. FDA does not exist under the EU system/  In the new EU MDR there will be the consultancy offered for clinical trial feedback, but that is really the only option.  If you want to have a review done by your Notified Body of technical documentation, clinical evaluation, etc., this has to be done under a formal application and they will give you feedback, but it will be in the form of deficiencies of the file.  And you have to pay for this.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 01-Aug-2019 04:02
From: Roger Gray
Subject: Notified Body Review

Some NBs used to offer this type of service, Anon, such as reviewing clinical strategy documents, but the European Commission has recently deemed such activity to be "consultancy" which, under the MDD/MDR, NBs are not allowed to provide. So the simple answer is "No".

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 31-Jul-2019 14:22
From: Anonymous Member
Subject: Notified Body Review

This message was posted by a user wishing to remain anonymous

Hi All,

Is there a process by which groups, such as bsi or TUV sud, perform pre-reviews of technical documentation prior to a company submitting an application? I guess it would be sort of like a pre-submission request in the US, except one would have to pay for it. I thought I saw this somewhere but not I cannot find it as a service.

Dear Anonymous,
Why would you take the time and money to go through a preassessment? Why not applying directly?
A prereview will not guarantee that the file will pass the "real" review!

What would be the advantage today?

------------------------------
Ludger Moeller
President, MDSS GmbH
lmoeller@mdss.com
------------------------------

Original Message:
Sent: 31-Jul-2019 14:22
From: Anonymous Member
Subject: Notified Body Review

This message was posted by a user wishing to remain anonymous

Hi All,

Is there a process by which groups, such as bsi or TUV sud, perform pre-reviews of technical documentation prior to a company submitting an application? I guess it would be sort of like a pre-submission request in the US, except one would have to pay for it. I thought I saw this somewhere but not I cannot find it as a service.

This message was posted by a user wishing to remain anonymous

​Under the MDD our NB used to offer consulting services.
I don't know if it is permitted under the MDR, but they clearly don't have the resources to do it now.
Maybe the best hope is to find a different consultant who has a great deal of experience with MDD submissions.
Original Message:
Sent: 31-Jul-2019 14:22
From: Anonymous Member
Subject: Notified Body Review

This message was posted by a user wishing to remain anonymous

Hi All,

Is there a process by which groups, such as bsi or TUV sud, perform pre-reviews of technical documentation prior to a company submitting an application? I guess it would be sort of like a pre-submission request in the US, except one would have to pay for it. I thought I saw this somewhere but not I cannot find it as a service.

As I said previously, your NB will not be able to offer these 'pre-submission' services under the MDR, because the Commission interprets this as 'consultancy', which is not permitted under MDD or MDR.

As you say, you need to use an experienced consultancy to provide this type of advice prior to submission to an NB.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 31-Jul-2019 21:24
From: Anonymous Member
Subject: Notified Body Review

This message was posted by a user wishing to remain anonymous

​Under the MDD our NB used to offer consulting services.
I don't know if it is permitted under the MDR, but they clearly don't have the resources to do it now.
Maybe the best hope is to find a different consultant who has a great deal of experience with MDD submissions.
Original Message:
Sent: 31-Jul-2019 14:22
From: Anonymous Member
Subject: Notified Body Review

This message was posted by a user wishing to remain anonymous

Hi All,

Is there a process by which groups, such as bsi or TUV sud, perform pre-reviews of technical documentation prior to a company submitting an application? I guess it would be sort of like a pre-submission request in the US, except one would have to pay for it. I thought I saw this somewhere but not I cannot find it as a service.