Class I Medical Device Registration

KhPat

Starting to get Involved
#1
Hello,

For Class I accessories used with medical devices which on their own do not have a measuring function, are these to be registered in the EU via EUDAMED. Also does anyone know how long it takes for competent authority to change user access from "viewer" to "proposer/ confirmer", i sent a request April 27 2022 and still have not heard back.

Hope someone can help.
 
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Ronen E

Problem Solver
Moderator
#2
Hello,

For Class I accessories used with medical devices which on their own do not have a measuring function, are these to be registered in the EU via EUDAMED. Also does anyone know how long it takes for competent authority to change user access from "viewer" to "proposer/ confirmer", i sent a request April 27 2022 and still have not heard back.

Hope someone can help.
This does seem a rather long wait, but in these pandemic days I guess anything is possible... Did you try the EUDAMED helpdesk?
Are you based outside the EU? Your EU rep should be assisting you with non-measuring non-sterile class I devices (accessories are regulated identically to devices).
 

KhPat

Starting to get Involved
#3
thank you for your response. Another follow up question if we register these class I devices in EUDAMED they will now full the MDR/MDD registration requirements?
 

Ronen E

Problem Solver
Moderator
#6
Our NB specifically requested us to register our legacy devices in EUDAMED last year, just sharing
Of course, under MDR... Or did they ask you to register them in EUDAMED while still under MDD certification only? Were these non-sterile non-measuring class I devices...?
Also, "requested" = "asked" or "required"?

BTW, until EUDAMED is officially declared "fully functional" (currently planned in H1 2023), its use is not legally mandatory. I know that some tasks under MDR CE marking can be challenging while completely avoiding EUDAMED, just saying...
 

Junn1992

Quite Involved in Discussions
#7
Or did they ask you to register them in EUDAMED while still under MDD certification only?
Yes while still under MDD, so we just went ahead and got a BUDI and UDI for these legacy devices, and designed new labels.
Also, as we are not based in the EU, our AR also had this requirement so we just did it anyway. I guess the NB and AR are playing it safe.

Also, "requested" = "asked" or "required"?
More like "required"
 

Ronen E

Problem Solver
Moderator
#8
Yes while still under MDD, so we just went ahead and got a BUDI and UDI for these legacy devices, and designed new labels.
Also, as we are not based in the EU, our AR also had this requirement so we just did it anyway. I guess the NB and AR are playing it safe.


More like "required"
Thanks, good to know.

Your AR is not really in a legal position to require anything, especially something not spelled out in the regulations. At most, they might point out that the contract (which I assume you have with them) entitles them to terminate unless <X>. That being said, I've already seen ARs (mostly the bigger ones) bully manufacturers, pretty much similar to what NBs tend to do now. I guess they got inspired...
 

Junn1992

Quite Involved in Discussions
#9
That being said, I've already seen ARs (mostly the bigger ones) bully manufacturers, pretty much similar to what NBs tend to do now. I guess they got inspired...
I guess AR/NB are in a sort of privileged position right now because they are the limiting resource in the equation, for now.
 

KhPat

Starting to get Involved
#10
If we are to sell sensors which have sensor adhesives (to attach to patients), are the adhesives considered Class I in this case?

Sensors and adhesives are bundled with sensors when purchased.
 
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