Richard, I would have thought the whole point of MDD renewal would be to avoid struggling with MDR-esque requirements for another 5 years? And that the main practical trade-off would be that you "can't" change your MDD-certified device for another 5 years? However, I would think a company should be free to change the device and certify under MDR whenever it is ready, not have to wait 5 years just because it has an MDD certificate. This would mean paying for 5-year MDD renewal now, and again for x-year MDR certification, but if the change is important enough to be worth the extra cost, then that option should be open?
Depending on the competitive environment for your devices, I think there may also be a competitive trade-off, as manufacturers of devices that have MDR certification are likely to include this in their promotional activities.
I wouldn't expect either MDD renewal or certification under the MDR to be guaranteed. Of the two, If the NB is open to a 5-year MDD renewal, I would expect this path to be the more certain of the two.
PS I don't think facilities can be certified to either the MDD or the MDR, only medical devices?
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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-Jun-2019 04:15
From: Richard Vincins
Subject: MDD early renewal
If you do not think you will be ready for EU MDR Transition by 2021, then you should renew. However, with that said because renewal is not guaranteed and seeing companies struggle with renewal (already applied MDR-esque requirements) should be completely prepared for the renewal process. Your quality planning should account for any of those eventualities, as well doing gap assessment of current MDD technical documentation to ensure meeting continued increasing requirements.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 08-Jun-2019 20:55
From: Rashmi Pillay
Subject: MDD early renewal
Hi,
This is with reference to our facility in the US which has its MDD certificate expiring in 2021. The NB has provided the option of early renewal ( valid for 5 years from now) which needs to be applied this month. However in their notification, the NB mentions about the recertification audit & Fees, technical documentation sampling and also state that the renewal is not guaranteed.
Also if we do not apply for the renewal, we can continue with the existing MDD certificate ( until its validity – 2021) , however no significant change applications would be accepted beyond Nov 2019.
Does anybody have a similar experience or can you please advise what would be the best approach .
We would have wanted to go with the early renewal which gives the flexibility until May 2024 for total MDR compliance and until May 2020 to go ahead with the significant change application under the MDD.
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
W ellex.com
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