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Impact of MDR on Availability of Medical Devices in EU

Watchcat

Trusted Information Resource
#1
"The reports of my death are greatly exaggerated.” --Mark Twain

I don’t do tea leaves or crystal balls, but I do try to pay attention to the writing on the wall. In the wake of Corrigendum 2, it seems to be saying that the medical device industry is not likely to be dead in the EU any time soon. Maybe more like it's been prescribed a better diet and more exercise.

These are the results of my efforts to do a high-level analysis of the impact of the MDR and attendant limited NB capacity come May 26. These are NOT predictions. It gets cumbersome to caveat everything with "probably,' "likely," "it appears," etc, so I haven't. Please read these caveats in for yourself.

Like all things regulatory, there are undoubtedly exceptions to these sweeping generalizations, but…I think…not so many as to put them far off the mark. If you are aware of something big I missed, please share it in a comment.

Class I


Virtually all Class I devices currently on the EU market will still be there May 26. This includes self-certified, NB-certified, and up-classified.

Class II-III

About half of MDD-certified Class II-III devices still be on the EU market come May 26. Another third are likely to re-enter the market by the end of the year, as additional NBs are designated and designated NBs get their certificate factories cranked up and rolling. This leaves another third or so that will befall various fates. Some may yet re-enter the market, in 2021 or later, others are probably gone for good.

Healthcare Providers

Healthcare providers that have stocked up on disposables seem unlikely to experience much disruption. Those that have not, they will have to scramble to replace them with “equivalent” devices. No patients will be harmed. Well, no more than usual.

____________________________________________
MDD-CERTIFIED CLASS I


Class Is and 1m devices already required an NB under the MDD. They will not need an MDR-designated NB until May 26, 2024.

Class Ir devices did not need an NB under the MDD. Although they are being up-classified, they will not need an MDR-designated NB until May 26, 2024.

Class I software devices did not need an NB under the MDD. Although they are being up-classified, they will not need an MDR-designated NB until May 26, 2024

Virtually all other Class I devices did not need an NB under the MDD and will not need one under the MDR.

It appears that virtually all of the Class I medical devices that are on the market under the MDD will remain on the market after May 26.

MDD-CERTIFIED CLASSES II-III

As of now, it appears that about half of all devices that are MDD-certified as Class IIa, IIb, or III will still be on the EU market come May 26. The majority of the rest will be back on the market by the end of 2020, if their manufacturers choose to keep them there.

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. These devices can remain on the EU market without an MDR-designated NB for another 2-4 years.

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. Presumably these 40 NBs were still renewing MDD certificates through May 25 2019 and their staff feel no pressing need to seek employment elsewhere, so they are likely to offer MDD services through the transition, unless they fail to secure MDR designation.

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 whole new meaning to being “at an awkward age.”

If their manufacturers were very forward looking, they renewed their MDD certifications early to stay out of the fray entirely. This would put these devices in the same position as the devices in Groups A and B. But probably few of their manufacturers were so forward looking as to expect NB capacity to get this tight, so they 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 was designated 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 two groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early. Heh.

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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Watchcat

Trusted Information Resource
#3
I agree, but since they currently have no oversight, if their only products are Class I software devices, they can probably run under the radar for quite some time, assuming they don't have other products that require NB oversight.

The corrigendum bought those manufacturers that want their software devices certified under the MDR some time, but those that need to make a significant change to remain viable will have to move forward as if there were no corrigendum, including getting in queue with an NB.
 

Watchcat

Trusted Information Resource
#4
I have been wondering if the Class I devices that don't have an NB can also run under the radar without an EU authorized representative. If not, then, with greater liabilities, the EU reps might function as something like stand-ins for the NBs until the transition period runs out.
 

Watchcat

Trusted Information Resource
#6
Didn't know they had any, but I'm pleased to hear that they do. On the other hand, it seems to me that SaMDs must completely overturn the import/export framework. No borders in the cloud...
 
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