Defining what is a Medical Device Accessory and what isn't - Much Confusion

[mr.mike]

Hello again,

I'm having some difficulties interpreting how accessories are defined.

Perhaps it would help if I gave a quick summary of our system:
[Main Device] -> [USB Cable] -> [Computer] -> [Power Supply Adaptor]

So, I've got a couple of questions:

1) The "USB Cable", "Computer" and "Power Supply Adaptor", appear to fit the definition of "accessory" given in MDD 93/42/EEC, Article 1, Section 2(b). However, we are not technically the manufacturer of these (they are commercially available products which we've specced out and had independently tested & certified). As such, technically the manufacturers of these don't have any specific intention of them being used with our device. So I guess my question is: are these considered accessories given:
- that we (the DEVICE manufacturer) intend them to be uses with the system, but
- they (the ACCESSORIES manufacturers) have no specified intent one way or the other for these to be used in a MD system.

2) Can anyone recommend suppliers for these 3 accessories (USB, PC, Power-supply adaptor) that ARE intended for medical applications? The issue that we are having is that the suppliers of the PC and Power-Adaptor are continually changing their models, and each time, we are having to re-test and re-certify. Is there any way this can be avoided?

As always, guidance is greatly appreciated.
MM.

 

[The Specialist]

Re: MD Accessories: Much Confusion

Hello again,

I'm having some difficulties interpreting how accessories are defined.

Perhaps it would help if I gave a quick summary of our system:
[Main Device] -> [USB Cable] -> [Computer] -> [Power Supply Adaptor]

So, I've got a couple of questions:

1) The "USB Cable", "Computer" and "Power Supply Adaptor", appear to fit the definition of "accessory" given in MDD 93/42/EEC, Article 1, Section 2(b). However, we are not technically the manufacturer of these (they are commercially available products which we've specced out and had independently tested & certified). As such, technically the manufacturers of these don't have any specific intention of them being used with our device. So I guess my question is: are these considered accessories given:
- that we (the DEVICE manufacturer) intend them to be uses with the system, but
- they (the ACCESSORIES manufacturers) have no specified intent one way or the other for these to be used in a MD system.

2) Can anyone recommend suppliers for these 3 accessories (USB, PC, Power-supply adaptor) that ARE intended for medical applications? The issue that we are having is that the suppliers of the PC and Power-Adaptor are continually changing their models, and each time, we are having to re-test and re-certify. Is there any way this can be avoided?

As always, guidance is greatly appreciated.
MM.

Personally, I would not consider a PC as an 'accessory'...

I cannot see (without further interpretation of your requirements) how the manufacturer of any of the mentioned 'accessories' is of any importance beyond:

Suitability
quality
support (if required as part of a service agreement)
auditable QMS/ regulatory certifictation.

It may be possible (if concerned about product (supplied) changes) to identify like-for-like specifications for accessories.

 

[mr.mike]

Re: MD Accessories: Much Confusion

Why wouldn't the PC be considered an accessory?

I guess part of my confusion stems from the vagueness of the Article 1 definitions of "medical device" and "accessory"...to me, the distinction is blurry.

For example:
- Article 1, 2(a) states a medical devices as "...any instrument, apparatus, appliance,
software, material or other article, whether used alone or in combination..." (bold added by me).
- So, while the PC alone is NOT specifically intended for the purposes listed in 2(a), in COMBINATION with our device, it is.
- Same applies to the USB cable and power-supply that we provide. They are critical to the functioning of the system (and in this sense are intended to be used in combination for MD purposes), even though alone they have no specific MD intent.

The fact is that ALL these components are critical to the system functioning for its intended purpose, whereas alone they have no medical intent.

I apologize for my confusion on what are probably pretty straight forward definitions.
The reason I want to be clear is that we need to list all accessories in our Technical File, and I want to be certain I'm listing everything relevant.

 

[MIREGMGR]

I'm having some difficulties interpreting how accessories are defined.

are these considered accessories given:
- that we (the DEVICE manufacturer) intend them to be uses with the system, but
- they (the ACCESSORIES manufacturers) have no specified intent one way or the other for these to be used in a MD system.

Because you are the responsible Manufacturer of the Device, you are the determiner of what is an Accessory for the system, and you are responsible for suitability and control of that Accessory's design, manufacturing, etc.

The actual maker of the accessory, unless they happen to be a medical device maker in their own right or they make a product version for you with custom-specified features, has no responsibility for their product in regard to medical device regulatory requirements. That responsibility is all yours.

 

[MIREGMGR]

Re: MD Accessories: Much Confusion

The fact is that ALL these components are critical to the system functioning for its intended purpose, whereas alone they have no medical intent.

I agree that this synopsizes the decision-basis for what should be regarded as an Accessory.

 

[fcowdery]

Re: MD Accessories: Much Confusion

Hypothetical Situation: An OR Table has a number of options available such as drain pan or head rest, however in the absence of these options, the base intended use of the OR Table is not altered. these options only enhanced the peformance of the table and do not alter its original intended use.
Would it be appropriate to classify these items as Options or Accessories.

 

[MIREGMGR]

I regard this area as not being clearly defined by the MDD.

I use the following analysis, and regard it as justifiable under the current rules:

Status of a product depends on that product's marketing.

If a minor product is sometimes sold by itself...even if it's only intended to be used in conjunction with a major product...the minor product is either a device or an accessory.

If a minor product is only made available as an element of a major product, and isn't sold separately, then the minor product can be defined as an option.

Lots of "options" of this kind are made available separately, for instance when the major-product customer decides after the major-product purchase that they additionally want the capabilities provided by minor products A, B and C. In that case, my view is that A, B and C must be regarded as accessories or devices.

 

[fcowdery]

thank you.
That was how I interpreted this as well.
Since these "options" are useless without the main product, they are not considered viable med devs when sold separately and therefore are options and not accessories.

Thanks

 

[MIREGMGR]

Since these "options" are useless without the main product, they are not considered viable med devs when sold separately and therefore are options and not accessories.

If it matters, your comment is the exact opposite of what I proposed.

If a minor product is sold separately, for any reason and irrespective of whether its clinical use is "viable", it's either a device or an accessory.

Only if the minor product is not sold seperately can it be considered an option and not an accessory or device.

The analysis depends on marketing, not on intended use.