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Medical Device Symbol(s) on Accessories

Edugar

Starting to get Involved
#11
When should this symbol be included in the label?
  1. When updated ISO 15223-1, which includes this symbol, is approved
  2. When the MDR is in force (May 2020), even if the product is certified according to the MDD
  3. When the product is certified according to the MDR
Is there any problem to start including this symbol in the labelling right now?

Thanks!
 
#12
I can't see why you can't use the MD symbol now - it is not specifically prohibited; the only caveat is that it is not a harmonised symbol and therefore would need explaination in the IFU

I suspect I know the answer, but .... when is the new ISO 15223-1 expected to be published and when is it expected to be added to the harmonised list?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#13
It is acceptable to address MDR requirements not through compliance with a harmonized standard, so you don't have to wait for the standard.
The requirement is new to the MDR so unless you go for MDR compliance you don't have to include that symbol. As above, you can do it voluntarily though.
 

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