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The EU update affects a section on the permission to import or manufacture a medical device that does not have a predicate device

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PubMed Duzel, A., Vlainic, J., Antunovic, M., Malekinusic, D., Vrdoljak, B., Samara, M., Gojkovic, S., Krezic, I., Vidovic, T., Bilic, Z., Sjekavica, I., Djuzel, A.R., Knezevic, M., Sever, A.Z., Lojo, N., Kokot, A., Sever, M., Drmic, D., Seiwerth, S., Sikiric, P

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