title: New regulations on medical devices in Europe: what to expect?
abstract: Medical devices (MDs) contribute to improve quality and effectiveness of healthcare. The MD industry is a heterogeneous, innovative, dynamic and growing sector. The existing regulatory framework for MDs has been in place for 20 years and needed a revision. In September 2012, the European Commission published a proposal for a new regulation on MDs which was amended by the Parliament in October 2013. This new regulation aims to harmonize practices, increase transparency and guarantee a high level of health protection. We conducted an analysis of the proposal to highlight the major upcoming changes.
authors.affiliation: Hospices Civils de Lyon, Délégation à la Recherche Clinique et à l'Innovation, Siège Administratif, BP 2251, 3 Quai des Célestins, 69002 Lyon, France.
authors.forename: Alice
authors.initials: A
authors.lastname: Fouretier
authors.forename: Delphine
authors.initials: D
authors.lastname: Bertram
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies; D005060:Europe; D006801:Humans; D012926:Social Control, Formal
keywords: CE marking; European regulation; clinical investigations; medical device vigilance; medical devices; transparency; unique device identification