"...
depends on the truthfulness of the manufacturer..."
In biblical terms, I believe this is what is known as building your house upon the sand. It would also seem to negate a need for any regulations whatsoever, except as government-funded opportunities to create jobs and profits, and to inspire consumer confidence. It certainly suggests a lack of lessons learned from PIP.
Regardless, what I think you are saying is that previously they were supposed to notify the CA, instead of a notified body? But under the MDR, they will have to notify their notified body. However, since they are under Corrigendum 2 because they can't find a notified body, they can't apply for the C.A.P. with a notified body. One possibility is that they could be "required" to notify the CA instead, but I'm not going to dig through to ttry to figure out if a provision for this can be found in the gray of a voided MDD and the MDR and Corrigendum 2.
If they don't notify their CA, then I'm doubtful the CA has any way of knowing. If they notify their CA...who knows what the CA will do, most likely send them a form letter...perhaps informing them that they cannot make this change until they have applied for the C.A.P with a notified body, or perhaps the same form letter they have been sending out for decades, that may just acknowledge receipt of the notification. Either way, whenever they finally find an NB, it seems like it's a clean slate, and they just submit the changed design.
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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: 10-Feb-2020 02:58
From: Peter Reijntjes
Subject: EU MDR 2nd corrigendum
It basically starts with and depends on the truthfulness of the manufacturer to start a CE certification with a Notified Body when they want to market a significantly changed device on the market. As far as I know all class I devices are notified at the corresponding Competent Authorities (it is in the Netherlands). The CA have to oversee these manufacturers.
But that's nothing new, It always starts with the manufacturer being aware of their obligations and fulfil the regulatory requirement.
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
Original Message:
Sent: 09-Feb-2020 21:42
From: Julie Omohundro
Subject: EU MDR 2nd corrigendum
What happens if they make a change? If they didn't have an NB under the MDD, the NB they don't have can't rescind their certification. How would anyone know? The MDR certificate will be an original certificate, based on whatever design is submitted for review.
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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-Feb-2020 04:32
From: Bodo Mestmacher
Subject: EU MDR 2nd corrigendum
Hi Corey,
it is like you already indicated. The COR2 includes the extended transition for all class I products with a valid DoC under the MDD which now require the N.B. assessment.
(see https://www.quadras.de/2019/12/18/second-vortigendum-mdr-ivdr-approved-by-eu-parliament/)
But keep in mind any change Leads to a mandatory application of the MDR.
Best regards
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Bodo Mestmacher
Essen
Germany
Original Message:
Sent: 07-Feb-2020 11:15
From: Corey Jaseph
Subject: EU MDR 2nd corrigendum
Hello experts, I have a 2nd corrigendum question.
My understanding is that only class 1r, 1s, and 1m devices are extended to 2024.
However, we have a supplier who is telling us that dental impression materials have also been extended, and that I should read the 2nd corrigendum to confirm this.
I cannot find anywhere in the 2nd corrigendum where these particular materials are extended. My only thought is that they think these are upclassified perhaps due to nano particles and the upclassification means impression materials get to stay on the market as a class 1 device until 2024.
This doesn't make sense to me.
Anyone else have any insight or knowledge?
Thanks so much!
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Corey Jaseph RAC
Director of Regulatory Affairs
South Jordan UT
United States
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