EU classification for a Medical Device Accessory

R

rollymi

#11
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

Hi all,
I am new in this forum but I might say I have learnt so many things. Thanks a lot for that!


Hereby, I have finally a question for you as well. I was checking quite much the available information however it is not clear to me what should be my next step hereafter. I would like to kindly ask you for a little bit of help regarding accessories for medical devices according to MDD (93/42). As far as I know already we should approve them with the NB with all necessary technical Doc and so to say to treat them as a medical device.

If I make the TD according to STED is that ok?

It is not exactly clear to me how we should label them? All of our Accessories will be Class I registered. Should they also have CE mark from the main medical devices or not at all.
I will be very happy if somebody can help me?
Thank in advance.



Best regards to all
 
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shimonv

Trusted Information Resource
#12
Hi rollymi,
Welcome to the cove.
If I make the TD according to STED is that ok?
Yes, you can use STED format to make the TD. Also, have a look at the following guidance document from MHRA. I'm sure it will be helpful to you.

It is not exactly clear to me how we should label them?
Label them as you would a class II device - Manufacturer information and symbols like "consult instruction for use", etc.
You should put the CE mark (mark of conformity to the EU regulation) but without the identifying number of your notified body. This is because class I devices and accessories are self-declaration. This is the only labelling difference that I'm aware of.

Cheers,
Shimon
 
R

rollymi

#13
Hi Shimon,

thank you very, very much for your answer!

However, would it be possible for you to give me some hints for the labeling of Class II.

"Label them as you would a class II device - Manufacturer information and symbols like "consult instruction for use", etc. "


Our main medical device has 4 accessories.

Two of them are medical devices theirself (Class I). Beside the STED and the CE (without the identifying number of the notified body) on the accessories and detailed explanations in the IFU from the main MD, should I take care for something else?

The other 2 accessories are not medical devices but they will be rated also as Class I and will consequently follow the explanations above? Is that correct, at least I understand it like this.


Cheers,
Rollymi
 

shimonv

Trusted Information Resource
#14
Hi rollymi,
There are no labelling requirements specific to accessories. That is why I wrote "Label them as you would a class II device".

So, normally you would include the manufacture name, product name, part-number, S/N or LOT (if applicable), manufacturing/expiry date (if applicable), storage conditions (if relevant),EU rep, and CE mark without the identification of the notified body. For symbols, I suggest you go over ISO 15223 and and add whatever is neccesary.

Good Luck,
Shimon
 
R

rollymi

#15
[FONT=&quot]Hi [/FONT][FONT=&quot]Shimon,[/FONT]
[FONT=&quot] [/FONT]
[FONT=&quot]That is exactly what i wanted to hear. Thank you very much for your information.
[/FONT]
[FONT=&quot]You are gold for this forum!!![/FONT]
[FONT=&quot] [/FONT]
[FONT=&quot]Thanks a lot once again![/FONT]
[FONT=&quot]Cheers[/FONT]
 
B

Boggyb

#16
Interesting discussion, indeed!
I have an additional question:

I agree that you should label your accessories as the parent device, but how should you label spare parts/replacement parts?
I have a device, which is sold with a USB cable, a power supply or sometimes a power cord (internal power supply in the device). These parts are not classified as accessories, as they are part of the medical device.
How should these parts be labled when packed and shipped with the CE marked device? Would there be any difference if the parts later are sold and shipped individually as replacement parts?
 

moounir

Involved In Discussions
#17
I see that you are focusing on the definition of MDD. MDR is considering accessories similar to any Medical Devices. So you will need to label them as a Medical Device (Link)
So try to be clear on your technical document on the objective of your product and include the label of each component. The Technical Documentation Annex II is without ambiguity asking to list all of them and list variations (Power cable for different countries for example)
I hope this helps to see what will happen in a near future.
 
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