EU classification for a Medical Device Accessory

[shimonv]

Hi Fellows,
I see that MEDDEV 2. 4/1 does not deal specifically with accessories.
I have a class IIb device that is powered by a power supply which is a part of the basic kit.

Can I classify the power supply separately as a class I accessory (under rule 1 or perhaps rule 12) and include it in the declaration of conformity for the accessories which includes spare parts, carrying bag and such?

Appreciate your support!

BR,
Shimon

 

[Pads38]

Hi Shimon,

Your external power supply - is it a power supply or a battery charger?

If it is a power supply your device would have no function with out it, so it would have to be considered as part of the device.

If it is a battery charger your device would work without it. Perhaps even, it might not perform it's medical purpose whilst charging. Then it might be legitimate to classify it separately.

 

[shimonv]

Thanks Pads38,
The device is battery operated and the power supply charges the internal battery.
The device will continue to work with the power supply connected to it.

So let me see if I understand you correctly:
If an accessory or other component is an essential part of the device's ability to perform its intended use - then the accessory "inherits" the classification of the device and can be sold together with the device or separately as a spare part with reference to the system's Declaration of Conformity. Correct?

On the other end, if an accessory is not essential part of the device's ability to perform its intended use, e.g. suitcase - then it may be classified seperatly as a class I accessory although I don't see a real benefit in doing that. Correct?

My initial idea was to see to what extent it is possible to separate meaningful accessories like power supply from a higher classified device.

Any more thought out there? I know the EU regulation is ambiguous on many things but if you could provide a reference source it would be great.

Thanks,
Shimon

 

[Ronen E]

Thanks Pads38,
The device is battery operated and the power supply charges the internal battery.
The device will continue to work with the power supply connected to it.

So let me see if I understand you correctly:
If an accessory or other component is an essential part of the device's ability to perform its intended use - then the accessory "inherits" the classification of the device and can be sold together with the device or separately as a spare part with reference to the system's Declaration of Conformity. Correct?

On the other end, if an accessory is not essential part of the device's ability to perform its intended use, e.g. suitcase - then it may be classified seperatly as a class I accessory although I don't see a real benefit in doing that. Correct?

My initial idea was to see to what extent it is possible to separate meaningful accessories like power supply from a higher classified device.

Any more thought out there? I know the EU regulation is ambiguous on many things but if you could provide a reference source it would be great.

Thanks,
Shimon

I see some unnecessary confusion here. The MDD has a clear definition for accessories to medical devices (I wish the FDA was as clear on that subject).

If the item in question does not enable the device to perform its intended use, it's not an accessory to that device, per the MDD.

In my understanding, the first question to be asked is how the item is offered for sale. If it's only sold as part of a device and then maybe offered as a spare part to an existing user, the accessory question is irrelevant - it is an integral part of the device and shouldn't have an independent classification / DoC. Only if it is offered as a stand-alone add-on it might be an accessory. And then, the verdict comes down to the MDD definition.

At first impression a carry bag is not an accessory, it probably doesn't enable the intended use.

Can your device run on non-rechargeable batteries? If not, does it come initially pre-charged, so that the charger is only first required after a while?

 

[shimonv]

Thanks Ronen, interesting discussion.

I checked the MDD and that's what it says in the definitions section:

"This Directive shall apply to medical devices and their accessories. For the
purposes of this Directive, accessories shall be treated as medical devices in
their own right. Both medical devices and acces- sories shall hereinafter be
termed devices.
[...]

‘accessory’ means an article which whilst not being a device is intended
specifically by its manufacturer to be used together with a device to enable it
to be used in accordance with the use of the device intended by the
manufacturer of the device"

The device I am writing about cannot run on non-rechrachable batteries; it has a custom built-in battery that keeps this portable device working during a treatment. The charger is necessary to charge the battery or power the device while working.

So, coming back to the original question:
1. Is the power supply an accessory? NO, it is an essential part of the device. It cannot receive an independent classification.
Note: offering an item as a spare part does not mean it can receive its own separate classification.
2. Is a caring case an accessory? I think yes. It can function as a protective packaging while on the go. The same thing could be said of an extension cable, external speaks (I am using my imagination here) or any other thing if it can work with the device in a way which was intended / allowed by the manufacturer. Accessories can receive their own classification and DoC per MDD; in most cases it will be class I.

I'd welcome any other comments.

Thanks,
Shimon

 

[Ronen E]

Is a caring case an accessory? I think yes. It can function as a protective packaging while on the go. The same thing could be said of an extension cable, external speaks (I am using my imagination here) or any other thing if it can work with the device in a way which was intended / allowed by the manufacturer.

In my opinion that's an expansive interpretation of the MDD wording. I think that it's not enough that the item will interface with the device in a way that was allowed (or even intended) by the manufacturer. Rather, it's necessary that the device won't be able to perform as intended without the item at hand (or its equivalent, from another manufacturer), for it to be classified as an accessory to that device. In your example, if the device is likely to fail due to lack of protection on transit (and its regular/frequent transfer between locations is intended by the manufacturer), then the case might be considered an accessory.

Accessories can receive their own classification and DoC per MDD;

I agree with that statement.

in most cases it will be class I.

Maybe. It comes down to applying the MDD classification rules (Annex IX) to the accessory, once it is determined to be one.

 

[shimonv]

Thanks Ronen,
Our prospectives are very close but not quite the same..
So, how will you classify/treat items that are not necessary for the drive to perform its intended use? e.g. caring case, optional disk-on-key, extension cable, etc. You want to ship these items to the EU with your name, and they need to bare the CE mark, and your QMS conforms to the MDD.

Shimon

 

[Ronen E]

Thanks Ronen,
Our prospectives are very close but not quite the same..
So, how will you classify/treat items that are not necessary for the drive to perform its intended use? e.g. caring case, optional disk-on-key, extension cable, etc. You want to ship these items to the EU with your name, and they need to bare the CE mark, and your QMS conforms to the MDD.

Shimon

Not a problem.

If you ship all those items with the device, treat them as parts of the device. Just like you treat the electronic components inside the device, for instance. They conform with the CE marking requirements because they are integral parts of a device that conforms.

If you ship any of those items separately, as spare parts supplied as replacements for identical items that were initially supplied with / as part of the device, or as extra units for the device's user, they can still bear the CE mark because they are parts of a product that conforms and is CE marked.

Some items can even be sold stand-alone, having nothing in specific to do with your device (e.g. flash drives). Such items should or shouldn't be CE marked based on what they are, possibly with no connection to the MDD. If there's a CE marking directive (or more than one) that applies to them, they should conform with it and then be CE marked on their own right. If there are none, they shouldn't be CE marked at all. Not all products placed on the EU market need to be CE marked - it's a scheme with a clear (and limited) scope.

Cheers,
Ronen.

 

[shimonv]

Thanks Ronen. It's good closure

 

[Heena Thakkar]

Hello Folks,

Interesting discussion!

I have some basic questions when it comes to classifying accessory that goes along with a medical device.

1) Does accessory have to be qualified as medical device? As per MDD definition of accessory, my impression is that it's not necessary.

2) If the part qualifies as an accessory (meaning that it helps medical device achieving its intended purpose), it will be classified in its own right. Correct?

3) Can there be a situation where accessory automatically falls under the same class as that of medical device? If I am not wrong, it happens if the software is part of the device.

I appreciate the responses.

Heena