Consumer Rights Act - Medical devices excluded?

Bristol_Rover

Looking for some advice. I'm assisting a friend who has purchased a CPAP machine from a shop in London. I have a basic, but not exhaustive knowledge of consumer rights. The machine (which cost the best part of £1500) developed a fault within 2 months. Initially the company were responding to emails, but are now trying to fob him off, claiming medical devices are a special case and it must be taken up with the manufacturer. Naturally, the manufacturer says take it up with the retailer. I've copied the below correspondence from the retailer. They have ignored all follow up emails (and letters, included signed-for letters). I'd like to proceed to a small claim but I don't know whether the 'medical exemption' has any basis in law?

…………………………………

"Thank you for your message. We want to clarify something important regarding your rights in the UK for your CPAP machine.

Your device is a CE-certified Class IIa medical device, regulated under the MHRA (Medicines and Healthcare products Regulatory Agency).

This means the manufacturer not the retailer is legally responsible for repairing or replacing any internal system fault, including System Error 12. This is their product. Their responsibility. "

Under UK medical-device law, the manufacturer must:

• Investigate any device malfunction

• Repair or replace the device if the fault is internal

• Provide a direct complaint and warranty-handling process

• NOT shift manufacturer warranty obligations onto the retailer

You are also protected by the Consumer Rights Act 2015, which states:

• Defects related to manufacturing or internal malfunctions must be addressed by the manufacturer

• Repairs or replacements must be provided at no cost to the consumer

• Medical devices fall under strict manufacturer obligations due to safety regulations

…………………………………

MyRealNameToo

Presumably this was self funded and not provided by the NHS?

There is no carve out for medical devices in the CRA if you are buying them as goods. Things get much more complex if provided by the NHS etc but assuming thats not the case so no point going down that rabbit hole.

The CRA makes the retailer liable, that doesnt mean they can't outsource the inspection etc to the manufacturer and indeed there could be other reasons why the random retailer shouldn't try and fix medical devices themselves.

Bristol_Rover

Correct, a self-funded purchase.

unforeseen

https://forums.moneysavingexpert.com/discussion/comment/81880229#Comment_81880229

It makes it simpler if NHS. CPAP devices provided by the NHS are free and loaned to the user. Any faults will be dealt with by the respiratory dept as a replacement at no cost.

Andy_L

To me, that they have just said "UK medical-device law" rather than quoting an actual piece of legislation is an indication that they are talking nonsense

sheramber

https://forums.moneysavingexpert.com/discussion/6654880/consumer-rights-act-medical-devices-excluded

That doesn't stop THEM passing it to the manufacture to investigate/repair. but it will take longer than going direct.

Did the item come with a guarantee?

molerat

And the usual …… How did they pay ?

Okell

@Bristol_Rover - assuming that the purchase of this machine is covered by s3(2) of the Consumer Rights Act 2015, I'm not aware of any specific exemption from that legislation for medical devices or medical equipment.

If I were you (or your friend) and I wanted to pursue my statutory consumer rights rather than any warranty rights*, I'd go back to the seller and notify them that you believe that the Consumer Rights Act 2015 does apply to this device, and that you are treating their suggestion to refer it to the manufacturer as the seller's one attempt permitted under the Consumer Rights Act either to repair or to replace the device. Tell them that if the manufacturer cannot successfully repair or replace the device you reserve the right to claim a refund from the seller as per the Consumer Rights Act.

As others have said, it's unlikely that the seller has the ability either to diagnose or to fix the device themselves and that they will have to send it back to the manufacturer. So if they are telling you to send it to the manufacturer it will probably be quicker for you to do that rather than insist on the seller taking it back. The important thing is to make sure that you tell the seller you are treating their suggestion as their one permitted attempt to repair or to replace under the CRA, so that if the manufacturer can't fix it and you can't get a satisfactory resolution from them*, you can still go back to the seller for a refund.

The other question is how did your friend pay?

*All the above assumes that the Consumer Rights Act route is the way to go. Does the device have a manufacturer's warranty and does that warranty give your friend better rights than the legislation does? Only you and your friend can know that - we can't read the warranty, assuming there is one.

saajan_12

"Thank you for your message. We want to clarify something important regarding your rights in the UK for your CPAP machine.

Your device is a CE-certified Class IIa medical device, regulated under the MHRA (Medicines and Healthcare products Regulatory Agency).

This means the manufacturer not the retailer is legally responsible for repairing or replacing any internal system fault, including System Error 12. This is their product. Their responsibility. "

Under UK medical-device law, the manufacturer must:

• Investigate any device malfunction

• Repair or replace the device if the fault is internal

• Provide a direct complaint and warranty-handling process

• NOT shift manufacturer warranty obligations onto the retailer

You are also protected by the Consumer Rights Act 2015, which states:

• Defects related to manufacturing or internal malfunctions must be addressed by the manufacturer

• Repairs or replacements must be provided at no cost to the consumer

• Medical devices fall under strict manufacturer obligations due to safety regulations

Oddly unprofessional sounding email which makes it sound more like bluff and less like sound legal argument.

"This is their product. Their responsibility" - very casual language in contrast to the rest of the email.

"Uk medical-device law" - without a specified law or regulation? Also medical device isn't hyphenated.

"Not shift manufacturer warranty obligations onto the retailer" - irrelevant as consumer rights are separate to warranty rights.

"Repairs or replacements must be provided at no cost to the consumer" - correct, that's an obligation on the retailer ie them!

"due to safety regulations" - which, pray tell?

eskbanker

You are also protected by the Consumer Rights Act 2015, which states:

• Defects related to manufacturing or internal malfunctions must be addressed by the manufacturer

• […]

• Medical devices fall under strict manufacturer obligations due to safety regulations

And they can cite specific CRA clauses stating this?

Alderbank

You are also protected by the Consumer Rights Act 2015, which states:

• Defects related to manufacturing or internal malfunctions must be addressed by the manufacturer

• […]

• Medical devices fall under strict manufacturer obligations due to safety regulations

And they can cite specific CRA clauses stating this?

I very much doubt it since those clauses are paraphrased from the Consumer Protection Act 1987!

They are mixing up the CRA with the CPA. That's a little careless.

The 'UK medical-device law' is actually the Medical Devices Regulations 2002. It is an extremely technical document, perhaps the whole reply is a clumsy attempt to give a dumbed down response to the OP?

But overall it's more CRAP than CPAP 😄