Hello,
We are looking to market our new product in the EU Class II(a) medical device. I understand the basics if GDRP but what I am having trouble with is figuring out what goverment/agency regulates it. Is there a cerificate issued? If so by whom? Is there a published standard available that can be used to implement a compliant system?
Do we need to have a EU Rep specifical for GDRP?
I would apreciate any help. Our EU rep does not seem to know much about GDRP.
Frank
We are looking to market our new product in the EU Class II(a) medical device. I understand the basics if GDRP but what I am having trouble with is figuring out what goverment/agency regulates it. Is there a cerificate issued? If so by whom? Is there a published standard available that can be used to implement a compliant system?
Do we need to have a EU Rep specifical for GDRP?
I would apreciate any help. Our EU rep does not seem to know much about GDRP.
Frank