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Certification process for registered device

primavesvera

Involved In Discussions
#1
Hello,

Our device is currently self-certified as IVD medical device, as Other/General type and it is valid until next year 26th May 2022.

Due to the changes in the Regulation, we believe the rules are now better defined and we would like to certified it under MDR.

My question is - if we go to the NBs with request to certify the device under MDR, does it affect the self-certification under IVDD?

The last thing needed is a recall due to the suspension of the certificate. And, yes, we are aware of the timelines.

Any kind of help is highly appreciated.

Cheers!
 
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chris1price

Trusted Information Resource
#2
If you are correctly self-certified under the IVDD, then discussing the IVDR with your notified body should not effect your IVDD certification.

As you say, the timelines for IVDR certification are very tight and many notified bodies have backlogs of technical files to review. I would talk to the NB as soon as possible and establish what they need and how long it will take.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#3
Your NB expects this type of communication. I would reach out to your NB Industry engagement representative first to make sure your questions receive proper answers; Dont go in through the technical team first IMO.
 

LUFAN

Involved In Discussions
#4
There are plenty of firms that offer MDR Classification consultancy as well (most are lawyers). You can get their legal opinion on the matter and then use it as your basis of achieving MDR certification.
 
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