Since 2008 the European Medical Device Approval Process is undergoing a revision which is expected to be officially published in the first half of 2017. The new medical device regulation will include new requirements on implantable medical devices; and especially orthopedic devices and devices in contact with the spinal column. This new regulation does not include rules considering legacy devices but expect that these devices fulfill the new European requirements in order to be certified according to the new rules. In particular, orthopedic devices that were either based on equivalence and/or do not have their own clinical data over their expected lifetime will not have a possibility to be certified following the new rules in Europe. During this workshop TÜV SÜD experts will present you the new European requirements and discuss with you the pros and cons of the new system for both already approved and new planned certification in Europe.
Who should attend:
This event will benefit Regulatory Affairs and Quality Assurance staff from medical device manufacturing companies. The event will focus on implantable medical devices; and especially orthopedic devices and devices in contact with the spinal column.
About the speakers:
Dr. Basil Akra
Global Director – Clinical Focus Team
Clinical Centre of Excellence
Dr. Bassil Akra is the global director of the clinical centre of excellence at 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. Dr. Akra is leading various consultation processes of medical devices incorporating an ancillary medicinal substance with the different competent authorities designated by the Member States or the EMA. He is presenting worldwide as a senior field expert the requirements in Europe and is involved in the development of several European guidance documents and standards. He is member of the Europe-an 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.