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Medical Device Symbol(s) on Accessories

Kim B

Registered
#1
I'm reaching out for guidance as to applying the MD Symbol on the label for accessories. If the accessory is a cable, must the MD symbol be applied to the labeling?
Having difficulty obtaining guidance as to the requirement for MD Symbol designation. Appreciate any support you may provide.
 

Marc

Captain Nice
Staff member
Admin
#2
To clarify for me, MD = Medical Device? I *assume* we're talking EU MDR 2007/745 - Correct? Knowing this stuff helps me with thread titling and tagging.
 
Last edited:
#3
Hi Kim,
What exactly do you mean by "MD Symbol"? There is no such symbol in the ISO 15223-1 "Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied".

Shimon
 

Kim B

Registered
#4
Correct and yes MD=Medical Device. A cable is not considered a medical device as a stand along accessory until connect to the main device.
Just reaching out for the point in a guidance to push to the team.
I did try a search but did not see any relevant information as to this subject.
 
#6
I suppose its harmless, but there is no regulatory requirement for it. I am working with several medical device companies that sell products in the EU and their device label does not include a "MD Symbol". So, when it comes to a component, like a cable, or accessory I wouldn't worry about.
 
#7
To be clear - the current ISO 15223-1 does not have a symbol for 'Medical Device'
This is new requirements being brought in by the MDR.
The Medical Devices Regulation 2017/745/EU (‘MDR’) has new requirements that ask for various kinds of information to be indicated on the label of medical devices. To comply with this requirement within the short term and in a harmonised manner, before the international standard is available, MedTech Europe publishes the present guidance on symbols for the following information:
1. Medical device
2. Contains human blood or plasma derivatives
3. Contains a medicinal substance
4. Contains hazardous substances
5. Contains biological material of human origin
6. Contains biological material of animal origin
7. Sterilized using vaporized hydrogen peroxide
8. Translation
9. Repackaging
10. Single Patient Multiple use
The symbol is the letters 'MD' in a box, similar to 'Lot' symbol we are all familiar with.
 

Kim B

Registered
#8
Correct MD symbol is new requirement by MDR. Link to image if you google MD MDR Symbol.
I cannot attach actual link.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#9
MD symbol.png


MDR Article 2 defines "Accessory for a medical device" as follows:
(2) ‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
So it depends on the specifics of that cable and how it's intended to be used. If it fits the definition above, it's treated in the MDR as a device and that means the MD symbol is required.
 
#10
Thank you for the clarification, this is the exact information required for clarification. Since the cable will connect to parameters and support the intended use it will require the symbol. Very helpful.
 

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