Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Seeking some guidance.
My organization is a small to mid-sized device manufacturer located (and primarily doing business) in the US. We are ISO/MDSAP certified in a few other countries as well, but not CE marked or doing business in the EU. Our current AO is also a Notified Body based in the EU and we've noticed a couple things that have us considering a transitioning to another AO. 

1. Because of their resources dedicated to MDR, they are likely busy/in demand and thus we've noticed some lag-time (which is to be expected), but also a fairly sizable price increase over the last few years. 
   1. Can others confirm significant price increases with their AOs? I know this is hard to pin down with the AO anonymity, but perhaps consultants out there with a wide lens can confirm.
2. We've noticed another interesting paradigm where our auditors are of an EU mindset and thus are now tracking ISO 13485 and ISO 14971 "requirements" with their MDR filters on. In more than one case auditors have pulled back from a "debate" admitting we meet the requirement of the standard "but if we were CE marked..."
3. We're considering a move to an AO based in the US to try and avoid some of the baggage experienced with AO/NBs (e.g., UL, Intertek).
   1. Are we naïve to think that a US-based AO may not have as many CE-marked manufacturers?
   2. Has anyone in a similar situation recently transitioned to another AO with some lessons learned?  

Thank you in advance for any engagement.

This message was posted by a user wishing to remain anonymous

Yes, I have also experienced this same thing.  We have an ISO 13485 division that is just a component manufacturer - no finished devices.  Our previous AO was an NB and a nightmare.  They could not get the EU and finished goods out of their mindset.
We switched to an AO that was US based and are now paying 1/4 of the price and avoiding those arguments.
I highly recommend doing the same if you don't plan on selling into the EU in the future.  If you do have plans for future EU sales, you may want to keep the NB as most NBs are not accepting new clients.
Original Message:
Sent: 09-Jan-2023 19:30
From: Anonymous Member
Subject: Shopping Auditing Organizations

This message was posted by a user wishing to remain anonymous

Seeking some guidance.
My organization is a small to mid-sized device manufacturer located (and primarily doing business) in the US. We are ISO/MDSAP certified in a few other countries as well, but not CE marked or doing business in the EU. Our current AO is also a Notified Body based in the EU and we've noticed a couple things that have us considering a transitioning to another AO.

1. Because of their resources dedicated to MDR, they are likely busy/in demand and thus we've noticed some lag-time (which is to be expected), but also a fairly sizable price increase over the last few years. 
   1. Can others confirm significant price increases with their AOs? I know this is hard to pin down with the AO anonymity, but perhaps consultants out there with a wide lens can confirm.
2. We've noticed another interesting paradigm where our auditors are of an EU mindset and thus are now tracking ISO 13485 and ISO 14971 "requirements" with their MDR filters on. In more than one case auditors have pulled back from a "debate" admitting we meet the requirement of the standard "but if we were CE marked..."
3. We're considering a move to an AO based in the US to try and avoid some of the baggage experienced with AO/NBs (e.g., UL, Intertek).
   1. Are we naïve to think that a US-based AO may not have as many CE-marked manufacturers?
   2. Has anyone in a similar situation recently transitioned to another AO with some lessons learned?  

Thank you in advance for any engagement.