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Users won't return devices from pre-CE performance evaluation study

anoia

Registered
#1
We recently ran a lay user study in the UK for a self-test device that involved users taking the device home to use for a period of time before returning it with a number of self collected samples. We made it very clear the devices had to be returned. The devices are labelled as 'performance evaluation only' and no CE-mark appears on them. Due to the collection of bodily fluid samples as part of the study the whole thing is anonymised so we don’t have any contact details for the users.

We've had a number of users fail to return devices and are now refusing to respond to the clinic they are meant to return the device to. Our principal investigator is saying they are 'lost to follow up' and the clinic do not want to chase them anymore as they don't want to be accused of harassment.

We're yet to do a risk analysis of the situation but are already thinking we'll need to provide pre-paid mailing envelopes for the clinic to pass onto the users to return the devices, as they clearly don't want to take the device back to the clinic they collected it from.

Should we be treating this as a product recall even though there’s technically nothing wrong with the device (no design changes have been made post-study)?
Do we need to notify our NB and MHRA about this?
Anyone have any bright ideas about how to get our non-CE marked devices back?

:thanx:
 
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shimonv

Trusted Information Resource
#2
Hi Anoia,
Not sure what's the best approach but I wouldn't treat this situation as product recall for the very reasons you mentioned.

like with many things - it's best to start with risk analysis; that will help you determine how far you need to go with this: from nothing to MHRA.

It's not clear why they won't return the device. Could it be that it is uncomfortable / contaminated. Is it possible that they threw it away?

I think you need to move ahead one step at a time.


Shimon
 

anoia

Registered
#3
Hi Shimon
Thank you for your reply.
It's not clear to us why they won't return the devices either! Cynic that I am thinks it's laziness but it may be other reasons.

Oh well, better get on with the risk analysis!

Cheers
 

TheMightyWife

Involved In Discussions
#4
Just a thought, did you try contacting MHRA or your notified body for advice? They can be very useful and informative sometimes... ;)
 
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