Medical Device Recalls - Manufacturer's obligation for covering cost

[JoCam]

Hi All,

In the event of the MHRA recommending the recall of a Class IIa medical device due to a safety concern which was identified many years after the device was first CE Marked by the Notified Body, and via a potential concern and not an actual incident, is the manufacturer legally responsible for providing free of charge replacements or refunds?

Jo

 

[Marcelo]

Normally, yes.

Please note that the CE Mark is given by the manufacturer to the manufacturer, (on the manufacturer's responsibility), not by the notified Body (which only fulfills part of the conformity assessment procedure). Thus, the manufacturer is always responsible, including in regards to costs of a recall.

 

[JoCam]

Thank you Marcelo,

So is the manufacturer legally obliged to provide free of charge replacements or refunds, and if so should this be based upon how long they have been using the device?

Jo

 

[Marcelo]

Oh, sorry, I did answer the full question, what he should do it really dependent on what the specific regulatory requirements are, and generally are agreed with the regulator that enforced the recall. The notified body may also have a say on this. So you need to talk to them to verify what they expect you to do.

 

[Marcelo]

See, for example, this document - A Guide to Defective Medicinal Products.

 

[JoCam]

Thank you again Marcelo, but the document you've referenced only covers medicines. Is there an equivalent for devices?

Jo

 

[Marcelo]

Yes, I know, but the basic idea is the same.

I don't remember having a recall guidance for devices in the UK.

 

[Marcelo]

Also, if you want to take a look at the regulation itself, see The Medical Devices Regulations 2002, item 62 - Compliance notices.

 

[JoCam]

I've looked through all the regulations and directives, and as always they aren't specific enough for me.

Thanks again,

Jo

 

[Ronen E]

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?