Laboratory-Developed Tests in the New European Union 2017/746 Regulation: Opportunities and Risks

Affiliations

• ¹ Institute of Laboratory Medicine, University Hospital, LMU Munich, Germany.
• ² Department of Hematology, University Hospital Schleswig Holstein, Kiel, Germany.
• ³ Center for Integrated Diagnostics, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.
• ⁴ Institute of Pathology, University Hospital Heidelberg, Heidelberg, Germany.
• ⁵ Institute of Medical Device Law, Faculty of Law, University of Augsburg, Germany.