Certification process for registered device

[primavesvera]

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!

 

[chris1price]

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]

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]

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.

 

[primavesvera]

First, thank you all for sharing your point of view.

The biggest problem is that we don't have NB at the moment since it wasn't necessary in the past due to the fact that device was self-certified.

I wouldn't want to jeopardize the current status of the devices by going to a NB to get the answer that the certificate will be invalid due to the change from IVDD to MDR (and, no, it is not IVDR) when the DoC under IVDD is still valid for almost an entire year.

The legal consultancy sounds as the best solution, at the moment.

 

[LUFAN]

First, thank you all for sharing your point of view.

The biggest problem is that we don't have NB at the moment since it wasn't necessary in the past due to the fact that device was self-certified.

I wouldn't want to jeopardize the current status of the devices by going to a NB to get the answer that the certificate will be invalid due to the change from IVDD to MDR (and, no, it is not IVDR) when the DoC under IVDD is still valid for almost an entire year.

The legal consultancy sounds as the best solution, at the moment.

I've never used Axon for classifications but I've read a ton of their position papers and Erik Vollebregt's presentations online. Might be a good starting point for you: A unique perspective to life science.

Where are you located? If you're outside of the EU, your (future) authorized representative if a third-party would also be a good option.

 

[Raisin picker]

If your current certificate is valid until May 2022, and you have not started certification under MDR already, prepare for a gap where you do not have a valid certificate. For the first certification, you should calculate 12 to 18 months, especially when your technical file has never been assessed before.
You definitely should start to talk to NBs.

 

[primavesvera]

I've never used Axon for classifications but I've read a ton of their position papers and Erik Vollebregt's presentations online. Might be a good starting point for you: A unique perspective to life science.

Where are you located? If you're outside of the EU, your (future) authorized representative if a third-party would also be a good option.

Thanks, I actually follow Erik's blog and quite value his point of view.

The problem is that this regulatory chaos is left by my predecessor and now it's up to me to clean it up.
I would definitely want to get the classification in order, however, at the same time I have to think about that potential gap on the market from 26th May 2022.

@Raisin picker, not to mention the potential clinical/performance evaluation, which has never been done before. Of course, I want to see with NBs, but my manager is afraid it would start an avalanche he wants to avoid.

Would it be possible to override the CE mark process and register the device directly with CA? Just for a couple of EU state members where we sell.

Thanks guys for the help.

 

[Raisin picker]

Well, a few things to consider:
- You have a self certified IVDD. I'm not an IVD person, but for MDR, you could certify your class I device until 2021-05-25 (that is, sign the declaration of conformity), an it will still be valid now. Is that possible with IVDDs as well?
- You claim that under MDR, your IVDD is a medical device. Ist this sure, or open to discussion/interpretation? Your first post suggests you "want to certify under MDR".
- A NB cannot force you to forfeit your DoC. They could, in theory, contact your CA about this. But if you play with open cards, they would assist you to find a legal way to become their customer.
- and last: I do sincerely hope that there is no way the CE certification process can be overridden (except maybe for limited house certifications).

Tell your manager that the avalanche will come sooner or later, and it will not be easier when it comes later.

 

[primavesvera]

Well, a few things to consider:
- You have a self certified IVDD. I'm not an IVD person, but for MDR, you could certify your class I device until 2021-05-25 (that is, sign the declaration of conformity), an it will still be valid now. Is that possible with IVDDs as well?
- You claim that under MDR, your IVDD is a medical device. Ist this sure, or open to discussion/interpretation? Your first post suggests you "want to certify under MDR".
- A NB cannot force you to forfeit your DoC. They could, in theory, contact your CA about this. But if you play with open cards, they would assist you to find a legal way to become their customer.
- and last: I do sincerely hope that there is no way the CE certification process can be overridden (except maybe for limited house certifications).

Tell your manager that the avalanche will come sooner or later, and it will not be easier when it comes later.

Unfortunately, I am not sure there is a similar transitional provision for IVDR. That would be the best solution.
At the same time, the device should have been certified as a medical device from the beginning, not an in vitro diagnostic device.

I have to correct myself.
Overriding - I have an information there were some countries that allowed medical devices to be registered without having CE mark, because the CA would perform the assessment. However, I am sure with MDR process this has been changed, but I just wanted to see if that still exists as a possibility.

Edit: I am trying to explain the seriousness of the situation, but everybody is so convinced that others will face the same problem and that it will not be possible to leave the EU market without this type of device.