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?
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.
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