Are we getting scammed by our Notified Body? They are asking to review all changes to determine if they are Significant

milandy

Registered
We're a US medical software company. We have an EU Class IIa device with a CE Mark. Our Notified Body insists that they, the Notified Body, must evaluate every single change we intend to make to our device, regardless of how small the change is, so they can determine if it is a Significant Change. These evaluations take weeks and cost min 1500 USD.

I'm new to this company and have not worked with this notified body previously. The notified bodies I worked with previously (BSI and Intertek) only required that we notify them of significant changes and it was up to us, the manufacturer, to determine what those were based on our own SOP. I would record the decision not to notify in a design impact assessment. This process has never been questioned.

Are we getting scammed?
 

Sidney Vianna

Post Responsibly
Leader
Admin
Are we getting scammed?
Good question. But one thing to be aware of is: The Notified Bodies are under INTENSE SCRUTINY and, just like the stock market, previous performance is no guarantee that things will be the same in the future.

You might attempt to establish a collaborative approach with your NB and have a clear understanding of the criteria used to identify a significant change. After all, risk based thinking should always be used in the determination of what needs NB review.

Good luck
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
NBs are currently swamped with MDR work. To integrate NB into EVERY QMS/device change is a risk.
 

Zero_yield

"You can observe a lot by just watching."
The notified bodies I worked with previously (BSI and Intertek) only required that we notify them of significant changes and it was up to us, the manufacturer, to determine what those were based on our own SOP. I would record the decision not to notify in a design impact assessment.

That's more or less how our process works, if it helps.
 
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