Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Can anyone recommend a Notified Body that is taking new clients for MDR Certifications?   My company has only one small family of devices so the file itself is not large.  Given the small size and scope of the file, I'm looking for a Notified Body that WON'T put me on a 2 year wait list.  If you believe there aren't any available Notified Bodies, do you have any suggestions for what we can do?

Additional Info: My company has a certified QMS through a large Notified Body that is designated under MDR, but they won't even look at our MDR Device File until 2024, which is nearly 2 years away and that is just to start the review.  Furthermore, they estimate 18 months review time for new files.  Therefor, by sticking with this Notified Body for our MDR certification, we would be looking at launching in EU in 2025/26, which is too long of a delay.

Hello Anon,

There are a couple other threads on this.  Good luck on the adventure :(.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Aug-2022 12:15
From: Anonymous Member
Subject: Notified Body MDR Certification Availability

This message was posted by a user wishing to remain anonymous

Can anyone recommend a Notified Body that is taking new clients for MDR Certifications?   My company has only one small family of devices so the file itself is not large.  Given the small size and scope of the file, I'm looking for a Notified Body that WON'T put me on a 2 year wait list.  If you believe there aren't any available Notified Bodies, do you have any suggestions for what we can do?

Additional Info: My company has a certified QMS through a large Notified Body that is designated under MDR, but they won't even look at our MDR Device File until 2024, which is nearly 2 years away and that is just to start the review.  Furthermore, they estimate 18 months review time for new files.  Therefor, by sticking with this Notified Body for our MDR certification, we would be looking at launching in EU in 2025/26, which is too long of a delay.

We submit next Monday for admin review. The technical review is in September. The current feedback is 18-24 months for clearance for MDR for us. If you dont have a NB yet I would assume its going to be a long haul :-(

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 09-Aug-2022 12:15
From: Anonymous Member
Subject: Notified Body MDR Certification Availability

This message was posted by a user wishing to remain anonymous

Can anyone recommend a Notified Body that is taking new clients for MDR Certifications?   My company has only one small family of devices so the file itself is not large.  Given the small size and scope of the file, I'm looking for a Notified Body that WON'T put me on a 2 year wait list.  If you believe there aren't any available Notified Bodies, do you have any suggestions for what we can do?

Additional Info: My company has a certified QMS through a large Notified Body that is designated under MDR, but they won't even look at our MDR Device File until 2024, which is nearly 2 years away and that is just to start the review.  Furthermore, they estimate 18 months review time for new files.  Therefor, by sticking with this Notified Body for our MDR certification, we would be looking at launching in EU in 2025/26, which is too long of a delay.

This is probably assuming you already have a quality management system certification and likely working with your current Notified Body. Don't forget that if you are new to the scene (start-up or no current ISO 13485/EU MDR or IVDR certificate) that you will need to start with a phase I quality management system audit and then phase II can be scheduled (assume Annex IX).

Also, MDCG issued a position paper (MDCG 2022-11) as a notification to manufacturers regarding timely compliance--link here.

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Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States
------------------------------

Original Message:
Sent: 12-Aug-2022 10:43
From: Ed Panek
Subject: Notified Body MDR Certification Availability

We submit next Monday for admin review. The technical review is in September. The current feedback is 18-24 months for clearance for MDR for us. If you dont have a NB yet I would assume its going to be a long haul :-(

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 09-Aug-2022 12:15
From: Anonymous Member
Subject: Notified Body MDR Certification Availability

This message was posted by a user wishing to remain anonymous

Can anyone recommend a Notified Body that is taking new clients for MDR Certifications?   My company has only one small family of devices so the file itself is not large.  Given the small size and scope of the file, I'm looking for a Notified Body that WON'T put me on a 2 year wait list.  If you believe there aren't any available Notified Bodies, do you have any suggestions for what we can do?

Additional Info: My company has a certified QMS through a large Notified Body that is designated under MDR, but they won't even look at our MDR Device File until 2024, which is nearly 2 years away and that is just to start the review.  Furthermore, they estimate 18 months review time for new files.  Therefor, by sticking with this Notified Body for our MDR certification, we would be looking at launching in EU in 2025/26, which is too long of a delay.