Medicinal products meet medical devices: Classification and nomenclature issues arising from their combined use |
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| Affiliation: | Department of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo 71, 20133 Milan, Italy |
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| Abstract: |  Download : Download high-res image (115KB)Download : Download full-size image |
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| Keywords: | Medicinal product Medical device Drug-device combination Combination product Integral product Co-packaged product Referenced products Companion diagnostic MP" },{" #name" :" keyword" ," $" :{" id" :" pc_h7iu6NeNUD" }," $$" :[{" #name" :" text" ," _" :" Medicinal Product MD" },{" #name" :" keyword" ," $" :{" id" :" pc_F2p2wJmxIb" }," $$" :[{" #name" :" text" ," _" :" Medical Device FDA" },{" #name" :" keyword" ," $" :{" id" :" pc_onb6irGoXH" }," $$" :[{" #name" :" text" ," _" :" US Food and Drug Administration EMA" },{" #name" :" keyword" ," $" :{" id" :" pc_uUEXUMAuTq" }," $$" :[{" #name" :" text" ," _" :" European Medicines Agency MDCG" },{" #name" :" keyword" ," $" :{" id" :" pc_eTx2a2h6KL" }," $$" :[{" #name" :" text" ," _" :" Medical Device Coordination Group MDR" },{" #name" :" keyword" ," $" :{" id" :" pc_okryeCMAw9" }," $$" :[{" #name" :" text" ," _" :" Medical Device Regulation MS" },{" #name" :" keyword" ," $" :{" id" :" pc_7whQlk9TVM" }," $$" :[{" #name" :" text" ," _" :" Medicinal Substance NB" },{" #name" :" keyword" ," $" :{" id" :" pc_LUm8I2yvtc" }," $$" :[{" #name" :" text" ," _" :" Notified Body CQA" },{" #name" :" keyword" ," $" :{" id" :" pc_SMgb0un5hT" }," $$" :[{" #name" :" text" ," _" :" Critical Quality Attribute GSPR" },{" #name" :" keyword" ," $" :{" id" :" pc_s8qbwMzG4v" }," $$" :[{" #name" :" text" ," _" :" General Safety and Performance Requirement CDx" },{" #name" :" keyword" ," $" :{" id" :" pc_xGtUPGvCdd" }," $$" :[{" #name" :" text" ," _" :" Companion Diagnostic IVD" },{" #name" :" keyword" ," $" :{" id" :" pc_YV8668khy3" }," $$" :[{" #name" :" text" ," _" :" in vitro Diagnostic Medical Device NCA" },{" #name" :" keyword" ," $" :{" id" :" pc_CKxUbwo33z" }," $$" :[{" #name" :" text" ," _" :" National Competent Authority |
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