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Input needed from MDR Gurus!

#1
I'm trying to work out a high-level look at the impact the MDR is likely to have on the number of medical devices on the EU market before and after May 26. Here's what I have so far. I would be happy to have any corrections, additions, suggestions, or other comments from some of the MDR gurus here might offer, as I am not one:

Timeframes Table.jpg


Groups A and B

These devices are in one of two situations:
  1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
  2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.
According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR. As of now, 9 have been designated. Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition.

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age." If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B. But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early. Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020. The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.
 
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