Labelling of an Accessory

[Yolanda74Moon]

Hello,

I have a Class III Medical Device which will be sold with an accessory as a system (two sterile pouches, packaged together in a box for single use).

As per MDR Annex II 23. 2(q), the MD symbol (ISO 15223 5.7.7) is present on the medical device (Class III).

Should the MD symbol be present on the label of the Accessory (Class IIa)?

Should the MD symbol be present on the outer packaging containing the system?

Thanks for your help!
Tom

 

[KShaw]

Hi there,

The GSPR call for all appropriate symbols and information to be placed on the device itself. If there isn't sufficient space (as in most cases), the manufacturer should place them on the next packaging level. So in your case, you can place the MD symbol on the sterile pouch. If you have space on the outer packaging, why not include the MD symbol there too?

You should include the MD symbol on the accessory's pouch too. Annex I 23.2q instructs to indicate that the device is a medical device. Funnily enough, the Regulation doesn't say, "If the product is defined as a medical device, indicate that it is a medical device". The way it's written, I would take it as all products covered by the MDR need to have the MD symbol.

Hope this helps!

Ken

 

[Yolanda74Moon]

Thanks Ken,

I will include the MD symbol on the accessory label.

In the meantime I have also been doing a bit of research and found a Q&A document published by Med Tech Europe which addressed this question.


Question 15
Label – do accessories to medical devices need MD symbol on their label?

Reference:
Annex I Chapter III Section 23.2. q)

Question:
GSPR indicate that a medical device shall be labelled as such and there is an existing ISO symbol for that – does the symbol also apply to accessories?

Solution :
If the accessory falls under the MDR and hence has a medical purpose, that accessory should have the MD symbol on its label. Such accessory will be indicated on the Declaration of Conformity. Should the accessory not be appropriately labelled the manufacturer may face questions from Notified Bodies and/or customs. General use configurable components & spare parts such as cables, computers etc. that do not fall under MDR do not need the symbol.

Rationale:
As per MDR Art.1.4 for the purposes of the MDR accessories to medical devices are also referred to as ‘devices’, for that reason accessories falling under MDR should also have the MD symbol on their label.


Have a nice day