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New regulations on medical devices in Europe: what to expect?
- Source :
- Expert Review of Medical Devices; Jul2014, Vol. 11 Issue 4, p351-359, 9p
- Publication Year :
- 2014
-
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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 17434440
- Volume :
- 11
- Issue :
- 4
- Database :
- Complementary Index
- Journal :
- Expert Review of Medical Devices
- Publication Type :
- Academic Journal
- Accession number :
- 96424168
- Full Text :
- https://doi.org/10.1586/17434440.2014.916209