title: Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?
abstract: Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the efficacy, safety and ideally, effectiveness of the technologies concerned. However, in the case of medical devices, such clinical data may not always be available, because of the different nature of the regulatory requirements in different jurisdictions. Therefore, we conducted a systematic review of the regulatory requirements in seven major jurisdictions in order to identify current challenges and to suggest possible improvements. There are differences in the requirements across jurisdictions and in the balance between pre-market and post-market controls. Several improvements are required in order to generate adequate clinical data for health technology assessment.
authors.affiliation: CERGAS (Centre for Research on Health and Social Care Management), Università Bocconi, Via Roentgen, 1 20136 Milan (MI), Italy.
authors.forename: Rosanna
authors.initials: R
authors.lastname: Tarricone
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Torbica
authors.forename: Francesca
authors.initials: F
authors.lastname: Ferré
authors.forename: Mike
authors.initials: M
authors.lastname: Drummond
mesh_terms: D003362:Cost-Benefit Analysis; D018795:Device Approval / Q000331:legislation & jurisprudence; D004864:Equipment and Supplies / Q000009:adverse effects / Q000145:classification / Q000191:economics*; D019317:Evidence-Based Medicine / Q000191:economics / Q000331:legislation & jurisprudence; D033161:Government Regulation; D017048:Health Care Costs / Q000331:legislation & jurisprudence; D006801:Humans; D062307:Medical Device Legislation / Q000191:economics*; D061214:Patient Safety / Q000191:economics / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing / Q000191:economics; D018570:Risk Assessment; D013673:Technology Assessment, Biomedical / Q000191:economics* / Q000331:legislation & jurisprudence
keywords: clinical evidence; health technology assessment; medical device; regulation; review