title: The new EU regulation on in vitro diagnostics: potential issues at the interface of medicines and companion diagnostics.
abstract: The new European regulation for in vitro diagnostics (IVD) divides the certification of IVD including companion diagnostics (CDx) by notified bodies (NB) from the market authorization of medicines. With the new regulation, CDx will require conformity assessment which is expected to include clinical evidence by NB. This is a significant change from the current situation: until now most IVD have been certified based on their manufacturers' assessment. For one medicine assessed by the EMA, certification of several different CDx by different NB is possible. As the benefit-risk balance of the medicine may depend on the performance (e.g., sensitivity and specificity) of its CDx, a close cooperation of EMA and NB will be necessary. The availability of detailed information on CDx used in the pivotal clinical trials for the medicine's authorization will become crucial for the assessment of alternative or competing CDx.
authors.affiliation: Bundesinstitut für Arzneimittel & Medizinprodukte, Bonn, Germany.
authors.forename: Harald
authors.initials: H
authors.lastname: Enzmann
authors.affiliation: Bundesinstitut für Arzneimittel & Medizinprodukte, Bonn, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Meyer
authors.affiliation: Bundesinstitut für Arzneimittel & Medizinprodukte, Bonn, Germany.
authors.forename: Karl
authors.initials: K
authors.lastname: Broich
mesh_terms: D000068:Accreditation; D003955:Diagnostic Tests, Routine / Q000295:instrumentation / Q000379:methods*; D005062:European Union; D033161:Government Regulation; D006801:Humans; D062307:Medical Device Legislation; D018570:Risk Assessment
keywords: CE mark; benefit–risk balance; certification; companion diagnostics; conformity; in vitro diagnostics; marketing authorization; medical devices; notified bodies; regulation