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New regulations on medical devices in Europe: what to expect?
Alice Fouretier1, Delphine Bertram
1Hospices Civils de Lyon, Délégation à la Recherche Clinique et à l'Innovation, Siège Administratif, BP 2251, 3 Quai des Célestins, 69002 Lyon, France.
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.
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