Medical Device Recalls - Manufacturer's obligation for covering cost

JoCam

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#11
We are talking about collection of deployed devices, right?
So customers have paid money and received devices in return, and once these devices are collected they will suffer economical (not to mention other) loss, unless they receive a free replacement or a refund. Doesn't seem right to me, but maybe I'm missing something.
If not the manufacturer, who else would cover the cost of such replacement or refund?
Hi Ronen,

I fully appreciate this and believe that the manufacturer should compensate the customer, I just cannot establish whether or not this is a legal requirement. I'm of the opinion that offering the purchase of a discounted replacement is adequate, as the device has in most cases already been in use up to the recommended lifetime without issue and for others at least 70% of the recommended lifetime.

As ever, I have it clear in my mind but would feel more comfortable with confirmation.

Thank you,

Jo
 
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pkost

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#12
The cost of recalls/FSCA's is not covered by the MDD, only that FSCAs shouuld be implemented. A manufacturer would normally cover the cost (and probably has insurance to cover this) for the simple reason that they are likely to upset their customers

Although the MDD does not cover who pays, there will almost certainly be other national legislation to cover this e.g. consumer rights act in the UK. Contracts are also likely to be in place between manufacturers/distributors to attribute costs from FSCAs
 

Ronen E

Problem Solver
Staff member
Moderator
#13
the device has in most cases already been in use up to the recommended lifetime without issue and for others at least 70% of the recommended lifetime.
IMO this would be relevant only if the labelling available prior to / at the time of purchasing clearly stated what was the lifetime that a customer should expect when they purchased the brand new unit. That could make a rational economical basis for a purchasing decision, and it would seem fair to ignore any expectations beyond such clearly stated lifetime. For devices with remaining theoretical life, I think the decent thing would be to offer customers a choice between a refund proportional with the remaining life, and purchasing a new unit at a discount at least proportional to the remaining life.
"Recommended lifetime" sounds a rather soft terminology - not sure what exactly it means.
 

JoCam

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#14
"Recommended lifetime" sounds a rather soft terminology - not sure what exactly it means.
Hi Ronen,

This is the lifetime that we recommend following v&v studies based upon worse case scenario. The device will in most cases still work after this time depending upon how much it has been used.

The lifetime is clearly stated in the User Manual that accompanies the device.

Jo
 

JoCam

Trusted Information Resource
#15
Although the MDD does not cover who pays, there will almost certainly be other national legislation to cover this e.g. consumer rights act in the UK. Contracts are also likely to be in place between manufacturers/distributors to attribute costs from FSCAs
Hi pkost,

I've reviewed the Consumers Rights Act and established that should a product be found to be of poor quality, does not work as described, is not safe or has not been manufactured to specification then the consumer has the right for replacement or refund. However, this seems to be based upon return of the product in the same condition as it was sold, which after 3 and a half years of use and annual servicing would not be possible in this instance. I'm sure there is something in this act that would offer a way around this, but I feel that providing a brand new and improved device as a replacement at a discount is fair.

Jo
 

pkost

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#16
I suspect (with the caveat that IANAL and UK only), that if someone has been using a product for 3 years and your instructions say you can only reasonably expect a 3 year life (even if it does last longer), then you have no obligation to the customer....Clearly the product has been working adequately in this time and they have obtained the benefit they paid for - they have not had a material loss
 

Ronen E

Problem Solver
Staff member
Moderator
#17
This is the lifetime that we recommend following v&v studies based upon worse case scenario.
Yes, that's pretty generic and I understood it. The problem is with the word "recommend", because it doesn't convey taking responsibility. If your wording conveyed that you guarantee a certain lifetime, then anything beyond that would have only been nice-to-have, and I agree with pkost that once that period is over there should be no obligations or expectations. But if the wording was conveniently vague it could work both ways and a customer could argue that since you weren't explicit they expected a longer life and are now disadvantaged.
The lifetime is clearly stated in the User Manual that accompanies the device.
Was that user manual available for review prior to the purchasing decision?
 

JoCam

Trusted Information Resource
#18
Yes, that's pretty generic and I understood it. The problem is with the word "recommend", because it doesn't convey taking responsibility. If your wording conveyed that you guarantee a certain lifetime, then anything beyond that would have only been nice-to-have, and I agree with pkost that once that period is over there should be no obligations or expectations. But if the wording was conveniently vague it could work both ways and a customer could argue that since you weren't explicit they expected a longer life and are now disadvantaged.

Was that user manual available for review prior to the purchasing decision?

Thank you Ronen,

Recommend is perhaps the wrong word, the lifetime of the device is clearly stated in the user manual as just that. In response to your question, yes, the User Manual is always made available prior to purchasing, as in the majority of cases the customers request an extensive 'Pre-Assessment Questionnaire' which requests information about the device as well as brochures, user and service manuals.

Jo
 
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