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Review
. 2014 Jul;11(4):351-9.
doi: 10.1586/17434440.2014.916209. Epub 2014 May 9.

New regulations on medical devices in Europe: what to expect?

Alice Fouretier  1 , Delphine Bertram
Affiliations
Review

New regulations on medical devices in Europe: what to expect?

Alice Fouretier et al. Expert Rev Med Devices. 2014 Jul.

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.

Keywords: CE marking; European regulation; clinical investigations; medical device vigilance; medical devices; transparency; unique device identification.

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