Richard, I think the key question is compliance with what, and by whom.
For the EC, it seems to me that compliance will not only be possible, but that the EC may have already complied with pretty much everything it has to comply with. It may have plans to do more, but it's not clear to me that it has to do more in order to comply. Same thing with the CAs.
Whether the industry is on track to comply, I will quote Houlihan:
The EC will not delay its timetable to suit industry. We have to remember the EC remit is to produce and implement directives and regulations. The EC's role is not to facilitate companies who have not planned nor started the required projects to implement these directives and regulations. The EC and the member states view is that the companies have had plenty of warning, the MDR existence is no surprise and Eudamed is coming in March 2020. Companies failure to plan, prepare, and implement their IT projects is not an issue for the EC, these are issues for the industry and the relevant companies. Recently the Commissioner for health and food safety, Vytenis Andriukaitis said, "any change of rules at this late stage would be unfair to serious operators that have carried efforts to ensure their timely compliance."
I am in no position to know whether this is spin or solid information, but I look forward to finding out. (Another interesting aspect of all of this is that it has presented a historic opportunity to assess the credibility of a wide range of information sources within the medical device space.)
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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: 09-Aug-2019 04:27
From: Richard Vincins
Subject: MDR deadline for Class I devices
Nope, no indication or movement this would be delayed. In the last 3 or so public statements by Erik Hansson as basically boiled down to: everything is on track for compliance. I will reserve any other statements because working primarily in EU MDR transitions last couple years, just the math alone does not add up to how this will all be possible. If you are a Class I, Reusable Surgical Instrument company or some of these software only applications now needing to "upgrade" to EU MDR by 26 May 2020 - only thing I can offer is good luck !
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 08-Aug-2019 17:14
From: Julie Omohundro
Subject: MDR deadline for Class I devices
As I understand the MDR (meaning I don't think I know), the MDR empowers the EC to publish harmonized standards and common specifications; it does not require it to do so. Also, as I understand it, conformance to the standards is not required under the MDR, any more than it was require under the MDD.
As for Eudamed, all I know is what I've read by Richard Houlihan:
https://www.linkedin.com/pulse/eudamed-myths-misinformation-richard-houlihan/
I'm really pretty sure that the MDR does not require the EC to designate any NBs, but only to provide its recommendation to the CAs. I'm not clear that it requires CAs to designate any NBs either, but seems only to authorize them to do so, if they are so inclined.
I don't see any reason for the EC to care how many people and organizations support an extension.
I will be as interested as anyone to see how this all plays out, but so far I've not found any motivation for the EC to delay any part of the MDR,
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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-Aug-2019 14:33
From: Vidya J
Subject: MDR deadline for Class I devices
Publish common specs and harmonized standards, set up EUDAMED (although this seems to have been postponed to 2021) and have enough MDR certified NBs, to begin with...
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Vidya
USA
Original Message:
Sent: 04-Aug-2019 21:18
From: Julie Omohundro
Subject: MDR deadline for Class I devices
What does the MDR require the EC itself to do by May 2020?
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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: 02-Aug-2019 03:31
From: Klaus-Dieter Ziel
Subject: MDR deadline for Class I devices
Hi Padraig,
class I devices and up-classified class I devices (e.g. class Ir reprocessing etc.) have a major disadvantage against all other devices (IIa, IIb and III) which can still be CE marked and put into the EU market depnding on the validity date of their current MDD certificate. As you mentioned, class 1 and up-classified class I devices must fulfill the MDR in May 2020.
The discussion about this disadvantage already started and it seems to me, that number of people and organisations supporting an extension of the May 2020 deadline, are steadily increasing. If the EC Commisison will react to this discussion and how they might react, is absolutely unknown at the moment.
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Klaus-Dieter Ziel
Hamburg
Germany
Original Message:
Sent: 01-Aug-2019 12:02
From: Padraig Maguire
Subject: MDR deadline for Class I devices
Is there any indication that the May 26, 2020 deadline for Class I MDD devices to be compliant with the MDR might be extended or modified? And this deadline is more difficult for those Class I MDD devices that will be up-classified to Class IIa or higher by the MDR rules and thus require a Notified Body CE certificate.
Thanks, Padraig
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Padraig Maguire
Head of Quality & Regulatory Affairs, S3 Connected Health
Dublin
Ireland
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