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EU MDD Class I Device market access / certification after 26th May 2020

kreid

Involved In Discussions
#1
Hello,
I have a question about MDD Class I devices, their access to the EU market after May 2020 and their reclassification due to new MDR rules.

If I have a software medical device that is currently classed as a Class I device under MDD Rule 12 and is marketed by way of a DoC stating compliance with MDD.
After 26th May 2020, Class I devices must comply with the EU MDR, presumably by producing a DoC that states compliance to the MDR.

However, my MDD Class I piece of software will be recertified, under MDR Rule 11, as a Class IIa device.

What do I do to maintain market access after 26th May 2020?

Thanks

K
 
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shimonv

Trusted Information Resource
#2
Hi Kreid,
In a nutshell, you have to comply with all the applicable requirements of the MDR, submit a technical file to one of the notified bodies for review, and be subject to their audit program. It's a very big jump from class I.
To date, DEKRA, TUV and BSI are designated notified bodies under MDR. You should contact them to get the ball rolling.


Shimon
 

kreid

Involved In Discussions
#3
Hi Kreid,
In a nutshell, you have to comply with all the applicable requirements of the MDR, submit a technical file to one of the notified bodies for review, and be subject to their audit program. It's a very big jump from class I.
To date, DEKRA, TUV and BSI are designated notified bodies under MDR. You should contact them to get the ball rolling.


Shimon
And I would have to do this transition by 26th May 2020?
Whereas for my existing Class IIa devices I can market them until their MDD cert expires!!
 

shimonv

Trusted Information Resource
#4
And I would have to do this transition by 26th May 2020?
Yes, I don't see a way around it for a self-declared device.

Whereas for my existing Class IIa devices I can market them until their MDD cert expires!!
A quote from MDR:

"Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024."
Check with your NB to see if you can extend your MDD CE certificate one last time (I know its possible).

Shimon
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Check with your NB to see if you can extend your MDD CE certificate one last time (I know its possible).
I assume you wrote that in the context of their MDD Class IIa devices. It's of course N/A to the Class I devices.

It's definitely time to panic. But hey, people have been talking about these issues only since May 2017...

MDR NB notes:
1. A fourth NB has been designated under MDR - IMQ from Italy.
2. With Brexit (possibly no-deal) looming on October 31st, I'd be cautious WRT BSI UK.
 
Last edited:

Watchcat

Trusted Information Resource
#6
And I would have to do this transition by 26th May 2020?
Whereas for my existing Class IIa devices I can market them until their MDD cert expires!!
Yep. Welcome to the EU party. Not sure if "better late than never" applies in this case.

I think your best (and I don't think it's much of one) hope is if the NB that holds your Class IIa MDD certificates is (or will be) designated under MDR. Then at least they might be available to work with you on this. It might not be able to keep your Class I on the market past May 2020, but it might be able to get it back on again in a matter of months, rather than a matter of years. (I don't think any NB designated under the MDR between now and May 2020 is going to be serving any companies that they weren't already serving under the MDD, except where they have a chance to pick up some really attractive new clients that got stranded. So it's probably your current NB or none at all.)

Also, if the NB that holds your MDD certificates hasn't already alerted you to this problem, it may mean that it doesn't expect to be certified under the MDR, or perhaps it does, but it doesn't especially want to take your company there with it. (I saw signs of NBs starting to jettison less attractive clients coming up for renewal over a year ago, not by saying so outright, but by picking up on reasons not to renew that it wouldn't have blinked at previously. I took it that they were starting to make room for more attractive clients that they could pick up when other NBs didn't make the MDR cut.)

Also also, I wouldn't rely too heavily on those MDD extensions, even if you get them. As I understand it, unless your contract obligates your current NB to continue to support your MDD certificates past May 2020 (i.e., by continuing to conduct audits). Otherwise, if it doesn't get designated under the MDR, it may reach a point where it doesn't make any business sense for it to continue, and it might just shut down its NB operations. At that point, your MDD certificates would be little more than historical relics.

Awake yet?
 
#8
Yes, your only option is to now apply for MDR in your new class and go through all the audit and Technical Documentation hoops prior to the May date. Unfortunately, just because if you somehow find a way to get all of your technical documentation and DoC created before then, you are at the mercy of your Notified Body even being able to schedule an audit in the near future - there is already a backlog for them. Which NB you have will greatly influence your future...BSI, DEKRA and TUV are designated now and are the largest NB's...and I bet they have a huge backlog. I'd contact your NB ASAP to discuss your situation.
 
#10
Hi Kreid,
It is important for Class I manufacturers to fully understand the classification changes between the MDD and the EU MDR.
Since decades, regulation of the medical device industry in Europe has been rather unchanged. However, recent events have now prompted for vital regulatory & compliance reforms to the medical devices industry. The new Medical Device Regulation adopted by EU, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive.
 
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