Regulatory Open Forum

Hi everyone,

This message goes out to anyone who's had their CER submitted for CECP review for the MDR application.  I'm trying to glean how much additional cost this incurs and if the review time defined in the Regulation is representative of how long it actually takes?  

Thanks in advance for sharing your experience,

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Hi Tina
I hope you have been following the public announcements of the CECP and PECP findings online. These are great resources to understand the types of issues our NBs have needed to address (or justify why they are not addressing the issues presented) after Expert Panel review. The Expert Panels have provided a list of NB deficiencies in their findings. Since we have been tracking this for my upcoming book on CERs/PERs, I find it interesting that some of these have taken about a year to get from NB review and through the Expert Panel to public release. I know we have a bunch in the pipeline for finalization and release as well. We have many more PECP than CECP, so the IVD Expert Panels seem to be more active (I guess this makes sense given the timing of COVID,and demands for IVD testing in particular),

Anyway, I'm just writing to say, I would not look at this as an "additional" cost since this is simply _the cost_ of getting CE Mark a class III / Implantable/class D device now. The Expert Panel is part of the required process in certain cases. We should not forget waht the NBs have to go through to get us our CE Marks. They, like all of us, are trying to improve!

Hope this helps and I hope you are doing well in New Zealand!

Best from Minneapolis, MN, USA.

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Original Message:
Sent: 18-Jan-2023 13:49
From: Tina O'Brien
Subject: CECP Review

Hi everyone,

This message goes out to anyone who's had their CER submitted for CECP review for the MDR application.  I'm trying to glean how much additional cost this incurs and if the review time defined in the Regulation is representative of how long it actually takes?

Thanks in advance for sharing your experience,

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Thanks for that Joy - this fee was not included in the quote from our NB, hence trying to understand if the CECP itself charges a fee and if that fee is payable directly by the applicant or as a pass-through from the NB.  My goal is to gain intelligence to assist with budget planning.  

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Original Message:
Sent: 18-Jan-2023 14:23
From: Joy Frestedt
Subject: CECP Review

Hi Tina
I hope you have been following the public announcements of the CECP and PECP findings online. These are great resources to understand the types of issues our NBs have needed to address (or justify why they are not addressing the issues presented) after Expert Panel review. The Expert Panels have provided a list of NB deficiencies in their findings. Since we have been tracking this for my upcoming book on CERs/PERs, I find it interesting that some of these have taken about a year to get from NB review and through the Expert Panel to public release. I know we have a bunch in the pipeline for finalization and release as well. We have many more PECP than CECP, so the IVD Expert Panels seem to be more active (I guess this makes sense given the timing of COVID,and demands for IVD testing in particular),

Anyway, I'm just writing to say, I would not look at this as an "additional" cost since this is simply _the cost_ of getting CE Mark a class III / Implantable/class D device now. The Expert Panel is part of the required process in certain cases. We should not forget waht the NBs have to go through to get us our CE Marks. They, like all of us, are trying to improve!

Hope this helps and I hope you are doing well in New Zealand!

Best from Minneapolis, MN, USA.

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com

Original Message:
Sent: 18-Jan-2023 13:49
From: Tina O'Brien
Subject: CECP Review

Hi everyone,

This message goes out to anyone who's had their CER submitted for CECP review for the MDR application.  I'm trying to glean how much additional cost this incurs and if the review time defined in the Regulation is representative of how long it actually takes?

Thanks in advance for sharing your experience,

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------