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The new EU regulation on in vitro diagnostics: potential issues at the interface of medicines and companion

Harald Enzmann1, Ralf Meyer1, Karl Broich1

  • 1Bundesinstitut für Arzneimittel & Medizinprodukte, Bonn, Germany.

Biomarkers in Medicine
|September 24, 2016
PubMed

Keywords:
CE markbenefit–risk balancecertificationcompanion diagnosticsconformityin vitro diagnosticsmarketing authorizationmedical devicesnotified bodiesregulation

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