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Verification of purchased product / Alexa as a medical device

Jamesv

Starting to get Involved
#1
Hi all

We are a small manufacturer of class 1 rehabilitation and communication aids /devices - we mainly 'modify' existing products to meet customers bespoke needs, but custom make some devices, in particular for people who have difficulty communicating to help them to access technology.

In modifying devices, we source materials pragmatically. For example, we might purchase large plastic push buttons that are robust from amazon. These may be the optimal components for a particular customers needs. Many manufacturers will not have extensive data sheets or run their own quality management systems; these parts are not being sold specifically to make a 'medical device', but may be the most useful component for us.

Similarly, we often incorporate products like Amazon Alexa into communication devices; its a pragmatic solution for severely disabled customers who need to use the internet. It is not sold as a medical device, but it isn't NOT sold as a communication aid for disabled people either.

Where do we draw the line and manage purchased product sensibly?

Thanks!

James
 

Schkund

Starting to get Involved
#2
Hi Jamesv! I was looking over FDA warning letters today so I have the following statement from one of these letters sitting right in front of me:

"Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body."

Of course this definition won't be quite as applicable if you're not selling to the United States, but if you break down what Alexa does in terms of this definition, it doesn't seem to fall into the category of medical device in the US (at least not from my interpretation). Yes, an Alexa can make life easier for those who are disabled or impaired in some way, but it is not "curing, mitigating, treating, or preventing" any disease, it isn't intended to diagnose a disease or condition, nor does it affect the structure/function of the body.

I hope this helps some!
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
Hi all

We are a small manufacturer of class 1 rehabilitation and communication aids /devices - we mainly 'modify' existing products to meet customers bespoke needs, but custom make some devices, in particular for people who have difficulty communicating to help them to access technology.

In modifying devices, we source materials pragmatically. For example, we might purchase large plastic push buttons that are robust from amazon. These may be the optimal components for a particular customers needs. Many manufacturers will not have extensive data sheets or run their own quality management systems; these parts are not being sold specifically to make a 'medical device', but may be the most useful component for us.

Similarly, we often incorporate products like Amazon Alexa into communication devices; its a pragmatic solution for severely disabled customers who need to use the internet. It is not sold as a medical device, but it isn't NOT sold as a communication aid for disabled people either.

Where do we draw the line and manage purchased product sensibly?

Thanks!

James
Hi James,

You should be managing suppliers and purchased goods (components) regardless of their designation as "medical" / "non-medical". For that decision, it's much more important what you do with them once you receive them. The general level of control (what measures you actually take) depends on the scheme under which the specific end-product in question comes (MDR health institution exemption, custom device etc.).

Cheers,
Ronen.
 

Jamesv

Starting to get Involved
#5
The general level of control (what measures you actually take) depends on the scheme under which the specific end-product in question comes (MDR health institution exemption, custom device etc.).
Thanks as always Ronen; we are applying ISO13485 to the MDR with an HIE. All of our devices (class 1) will be custom made, and components sourced according to risk vs benefit. Maybe in the technical file / device-specific documentation we could include a section 'where were the components sourced (if not from approved / certified suppliers) and why', as well as an assessment of risk? If we can have a plastic button delivered tomorrow with Amazon Prime, and our standard certified supplier will take 6 weeks, this may be sufficient if the component is physically inspected and found to meet our required standard?

I guess my question is really "what will an auditor make of us purchasing materials used in the manufacture of class 1 devices off Amazon?" I'm hoping they would be proportionate, as per the MHRA's draft guidance.
 

Tidge

Involved In Discussions
#6
We are a small manufacturer of class 1 rehabilitation and communication aids /devices - we mainly 'modify' existing products to meet customers bespoke needs, but custom make some devices, in particular for people who have difficulty communicating to help them to access technology.

In modifying devices, we source materials pragmatically. [...]

Where do we draw the line and manage purchased product sensibly?
I don't have direct experience with modification and marketing of other devices (recognized as medical devices or not) and sometimes marketing them as medical device while sometimes not marketing them as medical devices. My experience is with marketed medical devices only, most of which contain 'off-the-shelf' objects which are not medical devices themselves. I have a vague memory that there are specific regulatory guidance documents for businesses that do what you describe (customizing already marketed medical devices) but I'm blanking on details.

It appears to me that you make be lacking a procedural mechanism for assessing which of your products is a medical device and which are not. This is "drawing the line." It does appear that you have some idea that some of your products are medical devices. In the US, the assumption is that for those devices you will have an obligation to abide by the appropriate elements of 21 CFR 820, and by extension the necessary elements of 13485. For the 'button' example part 820 will require acceptance activities even if you escape the need for design controls. Compliance to 13485 will require appropriate purchasing controls.

One "line" I advise you not to cross: Don't market a device with medical claims if internally you don't recognize it as a medical device.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#7
'where were the components sourced (if not from approved / certified suppliers) and why', as well as an assessment of risk?
If you apply ISO 13485 across the board, all components that go into your products are initially in the scope. Then your Purchasing SOP can and should include provisions that make the requirements which apply in each case proportionate with the risk.
this may be sufficient if the component is physically inspected and found to meet our required standard?
This is termed "100% verification". 100% verification may be acceptable if the circumstances and conditions that allow it are clearly defined in your Purchasing SOP.
"what will an auditor make of us purchasing materials used in the manufacture of class 1 devices off Amazon?"
1. Auditors are not supposed to delve into class I devices (except class Im, Is & Ir devices of course). This is part of the essence of risk-based classification - lower risk, less scrutiny.
2. The MDR health institution exemption is worded such that where it applies the MDR doesn't. I would expect an auditor to suffice with a general check that the conditions for the exemption are generally met, not to go into great detail on how well each and every item and sub-item is implemented. The exemption requires "an appropriate QMS" - IMO an auditor should suffice with the existence of the QMS (I'll address appropriateness in a sec); not scrutinise in detail an element of the QMS - Purchasing in this case - or how well you apply it on a regular basis. The appropriateness of a QMS can be evidenced by an ISO 13485 certificate. If you were referring to the ISO 13485 auditor, they should be auditing you to the standard's wording (which promotes risk-proportional measures) and to your own SOP's wording. If you carefully consider the standard's wording and make appropriate provisions for purchasing from Amazon (for example) in your SOP, then stick to that SOP, you should be fine.

There's nothing to exclude Amazon (or the like) a-priori from being a supplier of medical devices components.

Custom-made devices require additional review, I don't have specific related experience.
 
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