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?
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?