Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

At what stage should a company engage and lock down on a Notified Body? Right after determining the classification of the device and before implementing the QMS (ISO 13485) or after development of QMS scope and implementation of ISO 13485 processes and procedure?

Thanks in advance

You should start as early as possible.  Even before classification of device or starting QMS system, engage in a NB to get them "in the wings" to at least understand if you can use them.  There are going to be limited number of NBs under the EU MDR/IVDR which will dictate how they throttle new clients into their audit scheduling and review schedule.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 03-Jul-2019 14:12
From: Anonymous Member
Subject: Notified Body

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

At what stage should a company engage and lock down on a Notified Body? Right after determining the classification of the device and before implementing the QMS (ISO 13485) or after development of QMS scope and implementation of ISO 13485 processes and procedure?

Thanks in advance

A year or so ago. :(

If you are a startup, my advice is "If you aren't already in the EU, don't go."  Even if you find an NB that will agree take you on, they are more likely to be locking you down than the other way around.  That is to say, they may sign you up, but they are unlikely to have the bandwidth to deliver services.

There are many other markets in the world.  Find them.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 03-Jul-2019 14:12
From: Anonymous Member
Subject: Notified Body

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

At what stage should a company engage and lock down on a Notified Body? Right after determining the classification of the device and before implementing the QMS (ISO 13485) or after development of QMS scope and implementation of ISO 13485 processes and procedure?

Thanks in advance

Recent comment on LinkedIn by Zimmer Biomet's VP RA/QA EMEA:

"...if you have not started and negotiated the renewals of your MDD CE certs by now, it is more than likely too late. All NBs are absolutely swamped."

This was his take on renewing certificates you already have, with an NB you already have, one of many NBs designated to issue and renew certificates under the MDD.  As of now, there are a total of two NBs designated to issue certificates under the MDR/IVDR.  And they are no doubt swamped with MDD renewals too.

You might consider working with a non-NB on ISO 13485 certification.  It has value well beyond the EU.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 05-Jul-2019 20:27
From: Julie Omohundro
Subject: Notified Body

A year or so ago. :(

If you are a startup, my advice is "If you aren't already in the EU, don't go."  Even if you find an NB that will agree take you on, they are more likely to be locking you down than the other way around.  That is to say, they may sign you up, but they are unlikely to have the bandwidth to deliver services.

There are many other markets in the world.  Find them.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 03-Jul-2019 14:12
From: Anonymous Member
Subject: Notified Body

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

At what stage should a company engage and lock down on a Notified Body? Right after determining the classification of the device and before implementing the QMS (ISO 13485) or after development of QMS scope and implementation of ISO 13485 processes and procedure?

Thanks in advance