Where to get EK MED 1927/16

H

Hideki2

Registered
#1
#1
Hello:

For a medical device, our notified body has asked for compliance with EK MED 1927/16. I'm looking for this regulation, but I can't find it. So would you tell me what kind of standard it is. Where can I go to get it?

Kind regards,

Hideki
 
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H

Hideki2

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#2
#2
I am sorry, but I need the information about symbols or labeling regarding to phtalates including medical devices in EK MED 1927/16.
 
Raisin picker

Raisin picker

Quite Involved in Discussions
#3
#3
I know EK-Med to be the "Erfahrungsaustauschkreises der nach dem Medizinproduktegesetz benannten Stellen (EK-Med)", which roughly translates to "Circle of experience exchange of the bodies notified under the Medical Devices Act". You can find their documents here, but ther eis nothingy that comes close to the number you provided. If your NB is from Germany, this might be the point to start, but I can't see anything that remotely resembles the number you got, or anything relating lo labeling.
I think it would be best to just call your NB and ask for clarification.
 
H

Hideki2

Registered
#4
#4
Hello Raisin picker:

Thank you for your reply. Now I understand this regulation. I will ask the point to the notfied body in details.

Kind regards,
Hideki
 
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