Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS community -

Has anyone ever utilized the appeal process with a notified body?  What happens after an appeal has been logged?

We currently have a technical file under review, and the NB is applying a local country specific guidance document to our file.  I'd like to raise a concern about this, but unsure how to address.  We've tried to resolve with the review team but we're not having much success.   Meanwhile, we are trying to address the concerns, but each time we address one - they identified another. 

Does the appeal process halt the review of the file?  How long can it take to resolve?   We're trying to determine whether we appeal now, or keep moving forward.

Thanks for any insight the collective team can provide.

I am not sure if you are talking about an appeals process with the Notified Body themselves or something else, but usually each NB appeal process is different.  Have you tried to escalate as much as you can within the NB?  The other course you have is to go directly to the National Authority or Competent Authority in the jurisdiction of your NB.  If you take this course though, your relationship with the NB will definitely change.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 28-Feb-2019 09:43
From: Anonymous Member
Subject: Appeal Process - Notified Body

This message was posted by a user wishing to remain anonymous

Dear RAPS community -

Has anyone ever utilized the appeal process with a notified body?  What happens after an appeal has been logged?

We currently have a technical file under review, and the NB is applying a local country specific guidance document to our file.  I'd like to raise a concern about this, but unsure how to address.  We've tried to resolve with the review team but we're not having much success.   Meanwhile, we are trying to address the concerns, but each time we address one - they identified another.

Does the appeal process halt the review of the file?  How long can it take to resolve?   We're trying to determine whether we appeal now, or keep moving forward.

Thanks for any insight the collective team can provide.