Dr. Bassil Akra is the vice president of the global strategic business development at the medical health service of TÜV SÜD Product Service. Dr. Akra has long experience in research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. He is presenting worldwide the requirements in Europe and is involved in the development of several European guidance documents and standards. He is member of the European Clinical Investigation and Evaluation working group and is representing Team NB and NB MED in several European discussions regarding the clinical requirements such as MEDDEV and other Guidance Documents on Innovative Devices. Dr. Akra is member of the German MDR Implementation Working Group, the NAKI. He is also member of the new MDR European task forces such as the one on PSUR, SSCP, Clinical Equivalence and sufficient clinical data.