title: Introduction of high-risk medical devices: national measures that can be taken under the current European legislation to put the patient interest central.
abstract: High-risk medical devices may not always provide a therapeutic added value to patients. In Europe, no proof of efficacy is required to receive a CE label, making it difficult for policymakers to decide on reimbursement of (often expensive) high-risk medical devices. We explore, within the framework of the European legislation, the possibilities at a national level for a guided introduction of such devices. Areas covered: HTA and legal experts worked in close collaboration with medical specialists and government representatives making a legal analysis of what is possible under the (revised) European and national legislation. Expert commentary: At national level, measures for a better evidence-based introduction can be taken that are not in contradiction with the European regulation. From a legal point of view, all restrictive measures must be justified, necessary and proportional. Several measures are possible, a.o. making use of reference centres, applying the IDEAL framework or the 6-step plan set up by the Dutch Order of Medical Specialists. In conclusion, within the framework of the (revised) European legislation, measures at national level can be taken to temporarily restrict and follow up the use of high-risk medical devices with a greater focus on the therapeutic added value for the patients.
authors.affiliation: a Belgian Health Care Knowledge Centre (KCE) , Brussels , Belgium.
authors.forename: Mattias
authors.initials: M
authors.lastname: Neyt
authors.affiliation: b CMS DeBacker, European law department , Brussels , Belgium.
authors.forename: Hanne
authors.initials: H
authors.lastname: Baeyens
authors.affiliation: c Equal, law firm , Brussels , Belgium.
authors.forename: Céline
authors.initials: C
authors.lastname: Pouppez
authors.affiliation: c Equal, law firm , Brussels , Belgium.
authors.forename: Pierre
authors.initials: P
authors.lastname: Slegers
authors.affiliation: a Belgian Health Care Knowledge Centre (KCE) , Brussels , Belgium.
authors.forename: Frank
authors.initials: F
authors.lastname: Hulstaert
authors.affiliation: a Belgian Health Care Knowledge Centre (KCE) , Brussels , Belgium.
authors.forename: Sabine
authors.initials: S
authors.lastname: Stordeur
authors.affiliation: a Belgian Health Care Knowledge Centre (KCE) , Brussels , Belgium.
authors.forename: Irm
authors.initials: I
authors.lastname: Vinck
mesh_terms: D004864:Equipment and Supplies; D005060:Europe; D006801:Humans; D062307:Medical Device Legislation; D012307:Risk Factors
keywords: Device approval; European union; equipement and supplies; government regulation; treatment outcome