Material from outside CER evaluation period

[Class]

Hi all,

I'm currently writing a CER (Class IIa device in case it matters) and am having a bit of an impasse among reviewers. The CER was written to evaluate clinical evidence obtained within a given time range. However, after that time range but before the CER was finalized, some of the information became obsolete. Does anyone know whether you should stick with the now-obsolete material given that it was relevant during the time covered by the evaluation? If you know of any sources would you be willing to point me in their direction so I can show my reviewers? Thanks in advance for any insight!

 

[Watchcat]

Really, given the state of things in the EU, I'd go with whichever is easiest. The world does not stand still. Any report of this nature is only a snapshot in time. The important thing is that the timeframe of the report be clearly identified.

If the obsolete information has a significant impact on the safety or performance profile of your device, I would still have no problem with leaving it in the report, finalizing it, and then, whenever the NB reviewed it, I'd advise reviewers of that fact. At that point, they might ask you to update the CER, but my best guess (!) is that this would not slow certification. You could also finalize the report, and start working on some type of addendum that addresses the impact of the obsolete material, so as to have it ready if the NB asks. Again, whichever is easiest would be my first choice, but I don't know all the details of your situation.

PS I'll eat my catnip if someone can point you to any official source that resolves this question for you.

 

[Ronen E]

I would first ask what "became obsolete" means? In a way, data never really gets obsolete - maybe irrelevant, not applicable, not submitable (invalid? problem) etc. Why is it now considered "obsolete" and how did that happen?

The best interpretive source I currently know on Clinical Evaluation is MEDDEV 2.7/1 rev 4, but it seems it needs its own guidance to fully interpret it! LOL.

 

[Class]

Thank you both. "Became obsolete" is referring to a preliminary hazard analysis and risk management plan. I edited the thread title to say "material" instead of "data". Upper management made a decision that those will no longer be performed and that this product shall be in its sunset years. Those 2 documents were in effect during the time of the evaluation period, though.

 

[Watchcat]

So, I think you may be saying that the device is certified under the MDD, but management has decided not to pursue its certification under the MDR? Further, that you started updating the CER thinking it would be needed to support MDR certification, but now you are doing it only to maintain the product's MDD certification, so you can continue marketing it in the EU for some period of time after May 26?

 

[Class]

So, I think you may be saying that the device is certified under the MDD, but management has decided not to pursue its certification under the MDR? Further, that you started updating the CER thinking it would be needed to support MDR certification, but now you are doing it only to maintain the product's MDD certification, so you can continue marketing it in the EU for some period of time after May 26?

Exactly

 

[Watchcat]

Well, now that we've got that sorted out...I'm probably not the best person to answer your question, lol. I think Ronen E is a better bet, so hopefully he will come back around shortly.

My own take is, when it comes to the CER, all the more reason to do what is easiest. No reason for anyone to care too much one way or the other, given the device is coming off the market in the foreseeable future, regardless.

My other take is that there may be much more reason for someone to care that your company seems to have decided to dispense with risk management for the remainder of the device's market life. As far as I know, risk management is a requirement of both the MDD and the MDR, so if the company has decided not to pursue the risk management plan, the CER may be the least of its worries.

Some of this depends on how much longer the company expects to keep the device on the market. and whether or not it will be able to get an NB to help it realize those expectations. The longer it is going to remain on the market, the more reason to care about what the company is doing (or not doing) with it while it is still there.

 

[Ronen E]

My other take is that there may be much more reason for someone to care that your company seems to have decided to dispense with risk management for the remainder of the device's market life. As far as I know, risk management is a requirement of both the MDD and the MDR, so if the company has decided not to pursue the risk management plan, the CER may be the least of its worries.

Some of this depends on how much longer the company expects to keep the device on the market. and whether or not it will be able to get an NB to help it realize those expectations. The longer it is going to remain on the market, the more reason to care about what the company is doing (or not doing) with it while it is still there.

I concur.

 

[Class]

Thanks again both of you