Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

What will be the status of MDR designation for the rest of the notified body applicants in 2020? Will we expect more NBs to be designated in the new year?  Thank you.

https://www.orielstat.com/blog/eu-notified-bodies-designation-status-mdr-2017-745/

Hello,

First, thank you for visiting our blog.  We do know there are probably another dozen Notified Bodies going through the designation process currently with say another 12 - 15 through 2020; many companies are hoping theirs will be designated before May 2020.  There is expectation there will be more Notified Bodies designated.  Based on the numbers having been published by Notified Body group, Medtech Europe and others, there may be about 30 Notified Bodies designated against the EU MDR.  However, keep in mind some of these Notified Bodies 1) may not designate to all product types and 2) may be limited in taking new clients due to resource constraints.  Notified Bodies need to have internal expertise for the devices they are reviewing.  So while there may be close to 30 when the last ones are designated, some of these Notified Bodies may not be taking on new clients in the immediate future as they work through implementing their own internal processes for EU MDR and type of devices they will review.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 05-Dec-2019 14:43
From: Anonymous Member
Subject: Status of MDR Designation

This message was posted by a user wishing to remain anonymous

What will be the status of MDR designation for the rest of the notified body applicants in 2020? Will we expect more NBs to be designated in the new year?  Thank you.

https://www.orielstat.com/blog/eu-notified-bodies-designation-status-mdr-2017-745/

I heard this week that "authorities" still expect to have 20 NBs sanctioned by years end (up from current 7-8). But your mileage may vary, as my source seemed a bit cynical.

More concerning is that I am hearing that NBs are pretty much telling companies there is no calendar room in 2020 for technical file audits. Basically, if you are not on the calendar already, good luck.

Ought to be an interesting year.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 05-Dec-2019 14:43
From: Anonymous Member
Subject: Status of MDR Designation

This message was posted by a user wishing to remain anonymous

What will be the status of MDR designation for the rest of the notified body applicants in 2020? Will we expect more NBs to be designated in the new year?  Thank you.

https://www.orielstat.com/blog/eu-notified-bodies-designation-status-mdr-2017-745/

Being more than a bit cynical, I will observe that "authorities" expected EudaMed to be ready on time, right up until it wasn't going to be ready.

Do you mean lack of calendar room for the already designated NBs, or are the NBs that are still hoping to be designated saying that they expect to be fully booked too, probably with existing clients.

As an aside, I'm starting to see "EU refugees" popping up in various forums, trying to find out how to get into other markets.  I expect this tide will be rising through much of 2020.  A colleague has also noted that there are a number of markets that probably don't have the resources to confirm whether a CE Mark is still valid, so they are looking for a lot of product with expired MDD CE marks to get dumped.

The most interesting year ever, from a device RA perspective.  Thirty years from now, the young ones here will be us, telling the newbies tales of how they survived the MDR, lol.

------------------------------
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: 06-Dec-2019 11:31
From: Ginger Glaser
Subject: Status of MDR Designation

I heard this week that "authorities" still expect to have 20 NBs sanctioned by years end (up from current 7-8). But your mileage may vary, as my source seemed a bit cynical.

More concerning is that I am hearing that NBs are pretty much telling companies there is no calendar room in 2020 for technical file audits. Basically, if you are not on the calendar already, good luck.

Ought to be an interesting year.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 05-Dec-2019 14:43
From: Anonymous Member
Subject: Status of MDR Designation

This message was posted by a user wishing to remain anonymous

What will be the status of MDR designation for the rest of the notified body applicants in 2020? Will we expect more NBs to be designated in the new year?  Thank you.

https://www.orielstat.com/blog/eu-notified-bodies-designation-status-mdr-2017-745/

Ginger and Julie ... oh just wait ... can not wait to see what 2020, 2021 and beyond brings from the EU !  (hysterical laugh)

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 06-Dec-2019 23:41
From: Julie Omohundro
Subject: Status of MDR Designation

Being more than a bit cynical, I will observe that "authorities" expected EudaMed to be ready on time, right up until it wasn't going to be ready.

Do you mean lack of calendar room for the already designated NBs, or are the NBs that are still hoping to be designated saying that they expect to be fully booked too, probably with existing clients.

As an aside, I'm starting to see "EU refugees" popping up in various forums, trying to find out how to get into other markets.  I expect this tide will be rising through much of 2020.  A colleague has also noted that there are a number of markets that probably don't have the resources to confirm whether a CE Mark is still valid, so they are looking for a lot of product with expired MDD CE marks to get dumped.

The most interesting year ever, from a device RA perspective.  Thirty years from now, the young ones here will be us, telling the newbies tales of how they survived the MDR, lol.

------------------------------
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: 06-Dec-2019 11:31
From: Ginger Glaser
Subject: Status of MDR Designation

I heard this week that "authorities" still expect to have 20 NBs sanctioned by years end (up from current 7-8). But your mileage may vary, as my source seemed a bit cynical.

More concerning is that I am hearing that NBs are pretty much telling companies there is no calendar room in 2020 for technical file audits. Basically, if you are not on the calendar already, good luck.

Ought to be an interesting year.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 05-Dec-2019 14:43
From: Anonymous Member
Subject: Status of MDR Designation

This message was posted by a user wishing to remain anonymous

What will be the status of MDR designation for the rest of the notified body applicants in 2020? Will we expect more NBs to be designated in the new year?  Thank you.

https://www.orielstat.com/blog/eu-notified-bodies-designation-status-mdr-2017-745/

Richard, seriously!  I've been looking forward to this for years!  

I think I started following "the new regulations" fairly closely in early 2013, when the voluntary joint assessments began. Seems like a good time for a quick trip down memory lane.  Maybe others here can add some milestones, confirm my dates?

2010 - PIP Scandal

January 2013 - Voluntary Joint Assessments begin (when there were 78 notified bodies)
October 2013 - Joint Assessments become mandatory (and then there were 59)
I think it was one or both of these programs kicked off a flurry of MDD certificates being withdrawn?

June 2016 - "White Smoke!" (heh)

April 2017 - MDR/IVDR are published!

January 2019 - First NB is designated under MDR
September 2019 - First CE certificate is issued under MDR
December 31, 2019 - A total of ??? NBs have been designated under the MDR

May 25, 2020 - Potentially one of the most interesting days in this whole saga.
May 26, 2020 - A total of ??? medical devices still available for sale in 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: 08-Dec-2019 13:44
From: Richard Vincins
Subject: Status of MDR Designation

Ginger and Julie ... oh just wait ... can not wait to see what 2020, 2021 and beyond brings from the EU !  (hysterical laugh)

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 06-Dec-2019 23:41
From: Julie Omohundro
Subject: Status of MDR Designation

Being more than a bit cynical, I will observe that "authorities" expected EudaMed to be ready on time, right up until it wasn't going to be ready.

Do you mean lack of calendar room for the already designated NBs, or are the NBs that are still hoping to be designated saying that they expect to be fully booked too, probably with existing clients.

As an aside, I'm starting to see "EU refugees" popping up in various forums, trying to find out how to get into other markets.  I expect this tide will be rising through much of 2020.  A colleague has also noted that there are a number of markets that probably don't have the resources to confirm whether a CE Mark is still valid, so they are looking for a lot of product with expired MDD CE marks to get dumped.

The most interesting year ever, from a device RA perspective.  Thirty years from now, the young ones here will be us, telling the newbies tales of how they survived the MDR, lol.

------------------------------
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: 06-Dec-2019 11:31
From: Ginger Glaser
Subject: Status of MDR Designation

I heard this week that "authorities" still expect to have 20 NBs sanctioned by years end (up from current 7-8). But your mileage may vary, as my source seemed a bit cynical.

More concerning is that I am hearing that NBs are pretty much telling companies there is no calendar room in 2020 for technical file audits. Basically, if you are not on the calendar already, good luck.

Ought to be an interesting year.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 05-Dec-2019 14:43
From: Anonymous Member
Subject: Status of MDR Designation

This message was posted by a user wishing to remain anonymous

What will be the status of MDR designation for the rest of the notified body applicants in 2020? Will we expect more NBs to be designated in the new year?  Thank you.

https://www.orielstat.com/blog/eu-notified-bodies-designation-status-mdr-2017-745/

<hysterical laugh> is right. Let's implement a major new regulation in the midst of great political upheaval, delegate huge responsibility to a "to be designated" group of 3rd parties who are given no guidance and thus feel free to make up requirements and who are also vastly understaffed, let the government get way behind setting up the infrastructure (as usual) but have no plan to delay or smoothly transition implementation. What could possibly go wrong over the next couple years?

Kind of makes me glad I am getting closer to retiring...

Ginger in MN

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 08-Dec-2019 13:44
From: Richard Vincins
Subject: Status of MDR Designation

Ginger and Julie ... oh just wait ... can not wait to see what 2020, 2021 and beyond brings from the EU !  (hysterical laugh)

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 06-Dec-2019 23:41
From: Julie Omohundro
Subject: Status of MDR Designation

Being more than a bit cynical, I will observe that "authorities" expected EudaMed to be ready on time, right up until it wasn't going to be ready.

Do you mean lack of calendar room for the already designated NBs, or are the NBs that are still hoping to be designated saying that they expect to be fully booked too, probably with existing clients.

As an aside, I'm starting to see "EU refugees" popping up in various forums, trying to find out how to get into other markets.  I expect this tide will be rising through much of 2020.  A colleague has also noted that there are a number of markets that probably don't have the resources to confirm whether a CE Mark is still valid, so they are looking for a lot of product with expired MDD CE marks to get dumped.

The most interesting year ever, from a device RA perspective.  Thirty years from now, the young ones here will be us, telling the newbies tales of how they survived the MDR, lol.

------------------------------
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: 06-Dec-2019 11:31
From: Ginger Glaser
Subject: Status of MDR Designation

I heard this week that "authorities" still expect to have 20 NBs sanctioned by years end (up from current 7-8). But your mileage may vary, as my source seemed a bit cynical.

More concerning is that I am hearing that NBs are pretty much telling companies there is no calendar room in 2020 for technical file audits. Basically, if you are not on the calendar already, good luck.

Ought to be an interesting year.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 05-Dec-2019 14:43
From: Anonymous Member
Subject: Status of MDR Designation

This message was posted by a user wishing to remain anonymous

What will be the status of MDR designation for the rest of the notified body applicants in 2020? Will we expect more NBs to be designated in the new year?  Thank you.

https://www.orielstat.com/blog/eu-notified-bodies-designation-status-mdr-2017-745/

Well, when you put it that way...

------------------------------
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: 09-Dec-2019 09:28
From: Ginger Glaser
Subject: Status of MDR Designation

<hysterical laugh> is right. Let's implement a major new regulation in the midst of great political upheaval, delegate huge responsibility to a "to be designated" group of 3rd parties who are given no guidance and thus feel free to make up requirements and who are also vastly understaffed, let the government get way behind setting up the infrastructure (as usual) but have no plan to delay or smoothly transition implementation. What could possibly go wrong over the next couple years?

Kind of makes me glad I am getting closer to retiring...

Ginger in MN

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 08-Dec-2019 13:44
From: Richard Vincins
Subject: Status of MDR Designation

Ginger and Julie ... oh just wait ... can not wait to see what 2020, 2021 and beyond brings from the EU !  (hysterical laugh)

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 06-Dec-2019 23:41
From: Julie Omohundro
Subject: Status of MDR Designation

Being more than a bit cynical, I will observe that "authorities" expected EudaMed to be ready on time, right up until it wasn't going to be ready.

Do you mean lack of calendar room for the already designated NBs, or are the NBs that are still hoping to be designated saying that they expect to be fully booked too, probably with existing clients.

As an aside, I'm starting to see "EU refugees" popping up in various forums, trying to find out how to get into other markets.  I expect this tide will be rising through much of 2020.  A colleague has also noted that there are a number of markets that probably don't have the resources to confirm whether a CE Mark is still valid, so they are looking for a lot of product with expired MDD CE marks to get dumped.

The most interesting year ever, from a device RA perspective.  Thirty years from now, the young ones here will be us, telling the newbies tales of how they survived the MDR, lol.

------------------------------
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: 06-Dec-2019 11:31
From: Ginger Glaser
Subject: Status of MDR Designation

I heard this week that "authorities" still expect to have 20 NBs sanctioned by years end (up from current 7-8). But your mileage may vary, as my source seemed a bit cynical.

More concerning is that I am hearing that NBs are pretty much telling companies there is no calendar room in 2020 for technical file audits. Basically, if you are not on the calendar already, good luck.

Ought to be an interesting year.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 05-Dec-2019 14:43
From: Anonymous Member
Subject: Status of MDR Designation

This message was posted by a user wishing to remain anonymous

What will be the status of MDR designation for the rest of the notified body applicants in 2020? Will we expect more NBs to be designated in the new year?  Thank you.

https://www.orielstat.com/blog/eu-notified-bodies-designation-status-mdr-2017-745/