Regulation of laboratory-developed tests and in-house in vitro diagnostic medical devices in the United States and the European Union-a comparative overview

Process chains in medical diagnostic laboratories lead to an accurate diagnosis and consequently to optimized personalized therapy recommendations. In addition to approved commercial in vitro diagnostic medical devices, devices and tests manufactured and used within a single diagnostic laboratory play a decisive role in these process chains ensuring state-of-the-art diagnostics and consecutive best patient care. It is vital that the implementation and use of such in-house tests, processes and medical devices developed in diagnostic laboratories by health care professionals is quality assured and meets regulatory and legal requirements. Due to the complexity and variety of these tests as well as their dual use in routine care and clinical trials, a thorough understanding of these regulations and their underlying definitions is critical. This review provides a comparative overview of the current state of the regulation of laboratory-developed tests in the United States and in-house developed in vitro diagnostic medical devices in the European Union. It dissects and compares the relevant regulatory ecosystems to identify conceptual similarities and differences. Our work helps laboratories navigate the regulatory landscape and provides a basis for further discussions among key stakeholders including health care providers, payers, legislators and regulatory agencies.