Many of us would love to see the results of the NB audits.
I should think there are those who can effectively lobby the EC as there are those who can effectively lobby Congress. I doubt that those who normally do this can be found standing outside the office in Brussels, though. If you can round up a hundred thousand or so people and garner the attention of the media, you might be able to make a dent from outside the office as well.
I get the busy work and motions of compliance, but...what reviews do you see as unnecessary?
------------------------------
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: 07-Mar-2020 07:16
From: Richard Vincins
Subject: Thoughts on MDD/MDR status
Unfortunately none of that information is publicly disclosed. You would have to contact each NB as a client or prospective client to understand where they are at in the designation process. Also I would love, love, love to see results of NB audits, the type of nonconformities they receive, and results of their quality system processes how effective they are against the requirements. Sadly, I doubt that will ever be the case. How can you lobby the EC ... go stand outside the office in Brussels with a big sign every day stating "Transparency." All you will get is a nice tan if it is sunny outside. It is still not about having patients first, but about creating busy work, charging for unnecessary reviews, and going through motions of compliance.
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 06-Mar-2020 22:38
From: Julie Omohundro
Subject: Thoughts on MDD/MDR status
How do we know how many are at each stage? What stages are you referring to? The only information I'm aware of is in the Rolling Plan, which hasn't been updated since December and has no stages, only the number that have been designated and the number that are in queue.
------------------------------
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-Mar-2020 06:32
From: Anonymous Member
Subject: Thoughts on MDD/MDR status
This message was posted by a user wishing to remain anonymous
Hello forum, happy Friday,
I look after RA for a UK manufacturer, we're a former LRQA client who finally (after a false start with one NB) has an MDD NB CE certificate again. We're now in the risky situation where we're better off than we were, but what if our MDD NB doesn't make it to MDR?
How can we lobby the EC (from the UK...) to publish more information on what status each NB is at with their designation? We know how many are at each stage but without names we're reliant on the word of our existing NBs. This might give some NBs a competitive advantage, but putting patients first should be priority. If our NB's futures are in doubt should we not know more now to be able to put plans in place and prevent supply problems?