title: Introduction of emerging medical devices on the market: a new procedure in Belgium.
abstract: When new medical technologies enter the market, there is often uncertainty about the added value for the patient and for society, hampering well-considered decision making about reimbursement. Current Belgian legislation already offered opportunities for the managed uptake of possibly innovative emerging implants. However, it has also some shortcomings such as the lack of a clear research design, rendering the scientific evaluation of clinical effectiveness, cost-effectiveness, and patient or organizational issues more difficult. Against this background, a new procedure was elaborated by the Belgian health insurance institute and the Belgian Health Care Knowledge Centre.
authors.affiliation: Belgian Health Care Knowledge Centre, Wetstraat 62, Brussels, Belbium. Imgard.vinck@kce.fgov.be
authors.forename: Imgard
authors.initials: I
authors.lastname: Vinck
authors.forename: Mattias
authors.initials: M
authors.lastname: Neyt
authors.forename: Nancy
authors.initials: N
authors.lastname: Thiry
authors.forename: Marleen
authors.initials: M
authors.lastname: Louagie
authors.forename: Dirk
authors.initials: D
authors.lastname: Ramaekers
mesh_terms: D001530:Belgium; D003132:Commerce; D004059:Diffusion of Innovation; D004864:Equipment and Supplies; D019317:Evidence-Based Medicine; D011050:Policy Making; D012051:Reimbursement Mechanisms; D013673:Technology Assessment, Biomedical / Q000458:organization & administration; D035501:Uncertainty