The New European Medical Device Regulation: Balancing Innovation and Patient Safety

Author:

Bretthauer Michael1ORCID,Gerke Sara2ORCID,Hassan Cesare3ORCID,Ahmad Omer F.4,Mori Yuichi5

Affiliation:

1. Clinical Effectiveness Research Group, University of Oslo, and Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway, and Institute of Clinical Medicine, University of Tromsø, Tromsø, Norway (M.B.)

2. Penn State Dickinson Law, Carlisle, Pennsylvania (S.G.)

3. Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Italy, and Humanitas Clinical and Research Center–IRCCS, Endoscopy Unit, Rozzano, Italy (C.H.)

4. Wellcome/EPSRC Centre for Interventional & Surgical Sciences, University College London, London, United Kingdom (O.F.A.)

5. Clinical Effectiveness Research Group, University of Oslo, and Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway, and Showa University Northern Yokohama Hospital, Digestive Disease Center, Yokohama, Japan (Y.M.).

Publisher

American College of Physicians

Subject

General Medicine,Internal Medicine

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